Paulness
15時間前
NEWS -- Plus Therapeutics to Showcase ReSPECT-LM Phase 1 Interim Data for Leptomeningeal Metastases at the 2024 San Antonio Breast Cancer Symposium
Company to present ReSPECT-LM Phase 1 trial data on Rhenium (186Re) Obisbemeda with a focus on treating leptomeningeal metastases (LM) in breast cancer patients
AUSTIN, Texas, Dec. 04, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, will present data at the 2024 San Antonio Breast Cancer Symposium, December 10-13, 2024 in San Antonio, Texas.
Presentation:
Title: Rhenium (186Re) obisbemeda (rhenium nanoliposome,186RNL) for the treatment of leptomeningeal metastases (LM): Update on Phase 1 dose escalation (Abstract Number: SESS-2271, Presentation ID: PS14-01)
Presenter: Andrew Brenner, M.D., Ph.D., Professor and Kolitz / Zachry Endowed Chair Neuro-Oncology Research; Co-Leader, Experimental and Developmental Therapeutics Program, University of Texas Health, Science Center at San Antonio
Date/Time: Friday, 13 December 2024 7:30-8:30 a.m. CST
Location: Stars at Night Ballroom 3-4, Henry B. Gonzalez Convention Center
About Leptomeningeal Metastases (LM)
LM is a rare complication of cancer in which the primary cancer spreads to the cerebrospinal fluid (CSF) and leptomeninges surrounding the brain and spinal cord. All malignancies originating from solid tumors, primary brain tumors, or hematological malignancies have this LM complication potential with breast cancer as the most common cancer linked to LM, with 3-5% of breast cancer patients developing LM. Additionally, lung cancer, GI cancers and melanoma can also spread to the CSF and result in LM. LM occurs in approximately 5% of people with cancer and is usually terminal with 1-year and 2-year survival of just 7% and 3%, respectively. The incidence of LM is on the rise, partly because cancer patients are living longer and partly because many standard chemotherapies cannot reach sufficient concentrations in the spinal fluid to kill the tumor cells, yet there are no FDA-approved therapies specifically for LM patients, who often succumb to this complication within weeks to several months, if untreated.
About Rhenium (186Re) obisbemeda
Rhenium (186Re) obisbemeda is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. Rhenium (186Re) obisbemeda has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. Rhenium (186Re) obisbemeda is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT).
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This presentation contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “potential,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the potential promise of rhenium (186Re) obisbemeda including the ability of rhenium (186Re) obisbemeda to safely and effectively deliver radiation directly to the tumor at high doses, and the potential commercialization of the Company’s products.
The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the early stage of the Company’s product candidates and therapies; the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash to fund its operations in the near term and long term, on terms acceptable to us or at all; the outcome of the Company’s partnering/licensing efforts; risks associated with laws or regulatory requirements applicable to the Company, including the ability to come into compliance with The Nasdaq Capital Market listing requirements; market conditions; product performance; litigation or potential litigation; competition within the cancer diagnostics and therapeutics field; ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms; manufacturing and supply chain risks; and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2023, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Charles Y. Huang, MBA
Director of Capital Markets and Investor Relations
Office: (202)-209-5751 | Direct (301)-728-7222
mailto://chuang@plustherapeutics.com
Paulness
2日前
NEWS -- Plus Therapeutics Expands Strategic Agreement with Telix IsoTherapeutics Group for Rhenium-186 Radioisotope Supply
Five-year renewable agreement secures reliable cGMP rhenium-186 (Re-186) supply for late-stage clinical and commercial forecasts
AUSTIN, Texas, Dec. 03, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV), a clinical-stage pharmaceutical company focused on developing innovative radiotherapeutics, today announced the renewal of its Master Services Agreement (MSA) with Telix IsoTherapeutics Group Inc. (‘IsoTherapeutics’, a Telix Group company). This MSA secures a reliable supply of cGMP Re-186, the radioisotope used in Plus Therapeutics’ lead radiotherapeutic candidate Rhenium (186Re) Obisbemeda.
“This continuing agreement with Telix IsoTherapeutics Group builds on our recently announced partnership with SpectronRx and reflects our comprehensive supply chain strategy,” said Marc H. Hedrick, M.D., Plus Therapeutics’ President and Chief Executive Officer. “By securing supply of Re-186 through IsoTherapeutics and leveraging SpectronRx for final drug manufacturing of Rhenium (186Re) Obisbemeda, we are establishing a scalable, end-to-end supply chain that positions us to meet the demands of late-stage clinical trials and future commercial needs.”
Key highlights of the agreement:
Focus on the production of key radionuclide intermediate aluminum perrhenate and the final processing of cGMP Re-186
Enables expanded, scalable, just-in-time manufacturing to support overall supply chainAbout Rhenium (186Re) Obisbemeda
Rhenium (186Re) Obisbemeda is a novel injectable radiotherapy specifically formulated to deliver direct targeted high-dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. Rhenium (186Re) Obisbemeda has the potential to reduce off-target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. Rhenium (186Re) Obisbemeda is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT).
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
About Telix IsoTherapeutics Group, Inc.
IsoTherapeutics was founded in 2005 by two entrepreneur scientists with a passion for advancing the technology of radiopharmaceuticals. IsoTherapeutics scientists have received over 100 patents for developing chemistry and radiopharmaceutical formulations. In April 2024 IsoTherapeutics was acquired by Telix Pharmaceuticals Limited (Telix) and now sits within the Telix Manufacturing Solutions business unit, a global network of facilities, infrastructure and technologies with the capability to supply patient doses worldwide and deliver on the promise of nuclear medicine. For more information, visit: https://isotherapeutics.com/
Cautionary Statement Regarding Forward-Looking Statements
This presentation contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “potential,” “anticipate,” “aim,” “expect,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the expected benefits of the renewal of the Master Services Agreement with Telix, such as meeting demands of late-stage clinical trials and potential future commercial needs, production of the key radionuclide intermediate aluminum perrhenate, including increasing shelf life of aluminum perrhenate, and the final processing of cGMP Re-186.
The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: reliance on third parties, including SpectronRx and Telix; the early stage of the Company’s product candidates and therapies; the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash to fund its operations in the near term and long term, on terms acceptable to us or at all; the outcome of the Company’s partnering/licensing efforts; risks associated with laws or regulatory requirements applicable to the Company, including the ability to come into compliance with The Nasdaq Capital Market listing requirements; market conditions; product performance; litigation or potential litigation; competition within the cancer diagnostics and therapeutics field; ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms; and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2023, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Plus Therapeutics Investor Contact
Charles Y. Huang, MBA
Director of Capital Markets and Investor Relations
Office: (202)-209-5751 | Direct (301)-728-7222
mailto://chuang@plustherapeutics.com
Paulness
1週前
NEWS -- Plus Therapeutics Presents Positive ReSPECT-LM Phase 1 Interim Data for Leptomeningeal Metastases at the 2024 SNO Annual Conference
Single intrathecal dose of Rhenium (186Re) Obisbemeda shows a favorable response rate and median overall survival in leptomeningeal metastases (LM) patients
Achieves up to 8x absorbed radiation dose to the CNS subarachnoid space vs. standard of care external beam radiation
Receives FDA agreement to initiate the ReSPECT-LM Phase 1 multiple administration dose escalation trial of Rhenium (186Re) Obisbemeda for LM
AUSTIN, Texas, Nov. 25, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, presented data updating the progress of its ReSPECT-LM Phase 1 clinical trial of Rhenium (186Re) Obisbemeda (Rhenium Nanoliposome, 186RNL) in leptomeningeal disease (LM). The data were presented at the 2024 Society for Neuro-Oncology (SNO) Annual Meeting November 21-24 in Houston, Texas.
“The combination of a high absorbed radiation dose, favorable safety profile, and consistent response data is very encouraging, particularly in a Phase 1 trial,” said Dr. Andrew Brenner, M.D., Ph.D. “Furthermore, the observed median overall survival rate and long tail survivors receiving multiple doses via compassionate use are uncommon in LM patients, driving our commitment to move rapidly into dose expansion and multiple-dose trials.”
The data were presented in a session titled, “Rhenium (186Re) Obisbemeda (rhenium nanoliposome,186RNL) for the treatment of leptomeningeal metastases (LM): Summary of the Phase 1 dose escalation study and Phase 2 administered dose selection,” by Andrew Brenner, M.D., Ph.D., Professor and Kolitz/Zachry Endowed Chair Neuro-Oncology Research; Co-Leader, Experimental and Developmental Therapeutics Program, University of Texas Health, San Antonio.
KEY HIGHLIGHTS
ReSPECT-LM Single Administration Dose Escalation Trial
Overview:
Twenty patients with LM were treated and evaluable through Cohort 5, receiving a single intrathecal dose of Rhenium (186Re) Obisbemeda of up to 66.14 mCi of radiation
Primary cancer diagnosis for the 20 patients with LM included breast cancer (n = 9), non-small cell lung cancer (n = 5), and other primary cancers (n = 6)Safety:
The safety profile through Cohort 5 was favorable, with 1 dose-limiting toxicity (thrombocytopenia) observed in Cohort 5
Pharmacodynamic and pharmacokinetic analyses indicated that after a single administration, Rhenium (186Re) Obisbemeda remained in the cerebrospinal fluid space for at least 7 days and achieved average absorbed doses of up to 253 Gy to the cranial subarachnoid space in Cohort 5Response:
The best clinical benefit rate from a single dose of Rhenium (186Re) Obisbemeda, assessed from baseline to day 112, was measured through complete response, partial response, and stable disease across three key metrics:
Circulating tumor cells: 93% (14/15 patients) responded, including 1 complete response and 1 stable case
MRI imaging: 75% (12/16 patients), with 5 responses and 7 stable cases
Clinical Response: 86% (12/14 patients), with 2 responses and 10 stable cases
Median overall survival for Cohorts 1-4 was 9 months, with 6 out of the 16 patients alive at the time of analysis
Three of the 20 patients received up to 3 doses of Rhenium (186Re) Obisbemeda under compassionate use IND, all surviving over 400 days, with one exceeding 30 monthsNext steps:
The first patient in Cohort 6 has been treated using a modified dose of 75 mCi
Cohort 6 is anticipated to conclude in Q1 2025
Planning is underway for a Phase 1b single dose expansion cohort trial using the Cohort 4 dose of 44 mCi, which is expected to fully enroll in 2025ReSPECT-LM Multiple Administration Dose Interval Compression Trial
Obtained agreement from FDA to begin the ReSPECT-LM multi-administration trial for patients with LM (IND 153715); enrollment is expected to begin in early 2025 at seven U.S. trial sites
The trial will be a two-part study aimed at evaluating the safety, dosing intervals, and efficacy of administering multiple doses of Rhenium (186Re) Obisbemeda to patients with LMAbout Leptomeningeal Metastases (LM)
LM is a rare complication of cancer in which the primary cancer spreads to the cerebrospinal fluid (CSF) and leptomeninges surrounding the brain and spinal cord. All malignancies originating from solid tumors, primary brain tumors, or hematological malignancies have this LM complication potential with breast cancer as the most common cancer linked to LM, with 3-5% of breast cancer patients developing LM. Additionally, lung cancer, GI cancers and melanoma can also spread to the CSF and result in LM. LM occurs in approximately 5% of people with cancer and is usually terminal with 1-year and 2-year survival of just 7% and 3%, respectively. The incidence of LM is on the rise, partly because cancer patients are living longer and partly because many standard chemotherapies cannot reach sufficient concentrations in the spinal fluid to kill the tumor cells; yet, there are no FDA-approved therapies specifically for LM patients, who often succumb to this complication within weeks to several months, if untreated.
About Rhenium (186Re) obisbemeda
Rhenium (186Re) obisbemeda is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. Rhenium (186Re) obisbemeda has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. Rhenium (186Re) obisbemeda is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT).
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This presentation contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “potential,” “anticipating,” “planning” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the planned dose expansion and multiple-dose trials of patients with leptomeningeal metastases; the timeline for completing the Company’s leptomeningeal metastases patient Cohort 6; the timeline for commencing the Company’s expansion trial of patients with leptomeningeal metastases; and timeline for the Company’s ReSPECT-LM multi-administration trial of patients with leptomeningeal metastases.
The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the early stage of the Company’s product candidates and therapies; the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash to fund its operations in the near term and long term, on terms acceptable to us or at all; the outcome of the Company’s partnering/licensing efforts; risks associated with laws or regulatory requirements applicable to the Company, including the ability to come into compliance with The Nasdaq Capital Market listing requirements; market conditions; product performance; litigation or potential litigation; competition within the cancer diagnostics and therapeutics field; ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms; manufacturing and supply chain risks; and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2023, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Charles Y. Huang, MBA
Director of Capital Markets and Investor Relations
Office: (202)-209-5751 | Direct (301)-728-7222
mailto://chuang@plustherapeutics.com
Paulness
2週前
NEWS -- Plus Therapeutics to Present Positive FORESEE Clinical Trial Summary Demonstrating Utility of CNSide™ Cerebrospinal Fluid Assay in Diagnosis and Clinical Management of Patients with Leptomeningeal Metastases
Prospective FORESEE trial of CNSide Cerebrospinal Fluid (CSF) Assay met key primary and secondary endpoints
CNSide CSF Assay influenced clinical management decisions in over 90% of leptomeningeal metastases (LM) cases
Assay demonstrated 2.8 times the diagnostic sensitivity vs. standard cytologyAUSTIN, Texas, Nov. 22, 2024 (GLOBE NEWSWIRE) -- CNSide Diagnostics, LLC, a wholly owned subsidiary of Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), will present data from the FORESEE trial showcasing the CNSide CSF Assay Platform’s utility in diagnosing and guiding clinical decision making for breast cancer and non-small cell lung cancer patients with LM. The data will be presented at the 2024 Society for Neuro-Oncology (SNO) Annual Meeting November 21-24 in Houston, Texas.
“Current gold standard CSF cytology lacks the sensitivity needed to reliably diagnose LM in most clinical situations and lacks utility for disease monitoring,” said Marc H. Hedrick, M.D., Plus Therapeutics’ President and Chief Executive Officer. “The FORESEE trial shows that CNSide may be a useful tool in accurately identifying all patients with LM, ruling out patients at risk, and enhancing the disease management and monitoring of LM.”
Key highlights:
The FORESEE trial achieved its primary endpoint, demonstrating that CNSide influenced treatment decisions in over 90% of cases evaluated, surpassing the predetermined 20% primary endpoint target
CNSide demonstrated enhanced sensitivity in detecting tumor cells (80%) vs. CSF cytology (29%) in patients with LM
CNSide identified actionable mutations in the CSF, such as HER2 amplification, influencing 24% of therapeutic selection decisions
CNSide exhibited high specificity, with no tumor cells detected in patients without LM
CNSide demonstrated improved Negative Predictive Value in ruling out LM (25%) vs. CSF cytology (10%)
CNSide revealed HER2 positivity in LM tumors in 60% of breast cancer patients with HER2-negative primary tumors, informing physician treatment strategiesThe data will be presented on Sunday, November 24, at 10:15 a.m. CST in a session titled, “CSF Tumor Cell (CSF-TC) Detection, Quantification and Biomarker assessment Helps in Clinical Management of Breast Cancer and Non-Small Cell Lung Cancer Patients Having Leptomeningeal Disease (FORESEE Study, NCT-5414123),” by Priya Kumthekar, M.D., Associate Professor of Neurology and Hematology/Oncology, and Director of Brain Metastases Program at Northwestern, University, Chicago, Illinois.
About CNSide Diagnostic, LLC
CNSide Diagnostics, LLC is a wholly owned subsidiary of Plus Therapeutics, Inc. that develops and commercializes proprietary clinical diagnostic laboratory assays, such as CNSid, designed to identify tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas. The CNSid Assay Platform enables quantitative analysis and molecular characterization of tumor cells and circulating tumor DNA in the cerebrospinal fluid that inform and improve the clinical management of patients with leptomeningeal metastases. The Company is planning to commercialize CNSide in the U.S. in 2025.
About CNSide Test
The CNSide Cerebrospinal Fluid (CSF) Assay Platform consists of four laboratory developed tests (LDTs) used for diagnosis, treatment selection, and treatment monitoring of patients with Leptomeningeal Metastases (LM) from carcinomas or melanoma. The CNSide platform facilitates tumor cell detection / enumeration and biomarker identification using cellular assays (immunocytochemistry (ICC) and fluorescence in situ hybridization (FISH)) and molecular assays (next generation sequencing (NGS)). The CNSide CSF tumor cell enumeration LDT is currently being used in the ReSPECT-LM trial as an exploratory endpoint, and is anticipated to become commercially available in 2025.
About Leptomeningeal Metastases (LM)
LM is a rare complication of cancer in which the primary cancer spreads to the cerebrospinal fluid (CSF) and leptomeninges surrounding the brain and spinal cord. All malignancies originating from solid tumors, primary brain tumors, or hematological malignancies have this LM complication potential with breast cancer as the most common cancer linked to LM, with 3-5% of breast cancer patients developing LM. Additionally, lung cancer, GI cancers and melanoma can also spread to the CSF and result in LM. LM occurs in approximately 5% of people with cancer and is usually terminal with 1-year and 2-year survival of just 7% and 3%, respectively. The incidence of LM is on the rise, partly because cancer patients are living longer and partly because many standard chemotherapies cannot reach sufficient concentrations in the spinal fluid to kill the tumor cells; yet, there are no FDA-approved therapies specifically for LM patients, who often succumb to this complication within weeks to several months, if untreated.
About FORESEE Clinical Trial
The FORESEE Study is a multi-center, prospective clinical trial enrolled patients with Breast or Non-Small Cell Lung Cancer (NSCLC) who have suspicious or confirmed Leptomeningeal Metastases (LM). Standard of Care methods to diagnose or assess the treatment response of LM (Clinical Evaluation, MRI and Cytology) have limited sensitivity and specificity. This creates challenges for physicians to manage LM or determine the best course of treatment. The goal of the FORESEE Study was to evaluate the performance of CNSide in monitoring the LM's response to treatment and to assess the impact of CNSide on treatment decisions made by physicians.
About Rhenium (186Re) obisbemeda
Rhenium (186Re) obisbemeda is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. Rhenium (186Re) obisbemeda has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. Rhenium (186Re) obisbemeda is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT).
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This presentation contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “potential,” “anticipating,” “planning” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the uses and benefits of the CNSide CSF Assay Platform, and predicted timeline for commercialization of the CNSide CSF tumor cell enumeration test.
The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the early stage of the Company’s product candidates and therapies; the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash to fund its operations in the near term and long term, on terms acceptable to us or at all; the outcome of the Company’s partnering/licensing efforts; risks associated with laws or regulatory requirements applicable to the Company, including the ability to come into compliance with The Nasdaq Capital Market listing requirements; market conditions; product performance; litigation or potential litigation; competition within the cancer diagnostics and therapeutics field; ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms; manufacturing and supply chain risks; and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2023, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Charles Y. Huang, MBA
Director of Capital Markets and Investor Relations
Office: (202)-209-5751 | Direct (301)-728-7222
mailto://chuang@plustherapeutics.com
Paulness
2週前
NEWS -- Plus Therapeutics to Present Multi-Institutional Experience Using the CNSide™ Cerebrospinal Fluid Assay in Patients with Leptomeningeal Metastases
CNSide Cerebrospinal Fluid (CSF) Assay analyzed 258 CSF samples across 66 leptomeningeal metastases (LM) patients at five institutions
CNSide identified extensive, actionable mutational changes, and clinically relevant longitudinal biomarkers
AUSTIN, Texas, Nov. 21, 2024 (GLOBE NEWSWIRE) -- CNSide Diagnostics, LLC, a wholly owned subsidiary of Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), will present data demonstrating the utility of the CNSide CSF Assay Platform in identifying mutations of key biomarkers in the CSF and their implications in treatment selection for LM. The data will be presented at the 2024 Society for NeuroOncology (SNO) Annual Meeting November 21-24 in Houston, Texas.
“The data from CNSide suggests that biomarker mutation profiles in LM are dynamic, offering valuable insights for treatment strategies,” said Marc H. Hedrick, M.D., Plus Therapeutics’ President and Chief Executive Officer. “The genetic drift observed in LM suggests an important role for radiotherapeutics such as Rhenium (186Re) Obisbemeda in addressing this challenging disease.”
Key highlights:
CNSide CSF Assay evaluated 258 CSF samples across 66 patients with LM to analyze clinically relevant biomarkers
Fourteen biomarkers were assessed, including 11 by fluorescent in situ hybridization (FISH) and 3 by immunocytochemistry (ICC); 12 of the 14 biomarkers demonstrated at least one change during treatment
CNSide CSF FISH analysis detected biomarker changes in 88% (58/66) of patients, with newly identified actionable biomarkers in 26 cases
CNSide CSF ICC analysis revealed biomarker changes in 20% (13/66) of patients, with newly identified actionable biomarkers in 7 casesThe data will be presented on Friday, November 22, at 7:30 p.m. CST in a session titled, “The Oncogenic Flip in Patients with Leptomeningeal Metastatic Disease (LMD): Longitudinal Detection in Cerebrospinal Fluid Tumor Cells (CSF-TCs) Reveals Implications for Differential Treatment of the LMD Tumor,” by Arushi Tripathy, M.D., from University of Michigan Department of Neurosurgery.
About CNSide Diagnostic, LLC
CNSide Diagnostics, LLC is a wholly owned subsidiary of Plus Therapeutics, Inc. that develops and commercializes proprietary clinical diagnostic laboratory assays, such as CNSide, designed to identify tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas. The CNSide Assay Platform enables quantitative analysis and molecular characterization of tumor cells and circulating tumor DNA in the cerebrospinal fluid that inform and improve the clinical management of patients with leptomeningeal metastases. The Company is planning to commercialize CNSide in the U.S. in 2025.
About CNSide Test
The CNSide Cerebrospinal Fluid (CSF) Assay Platform consists of four laboratory developed tests (LDTs) used for diagnosis, treatment selection, and treatment monitoring of patients with Leptomeningeal Metastases (LM) from carcinomas or melanoma. The CNSide platform facilitates tumor cell detection / enumeration and biomarker identification using cellular assays (immunocytochemistry (ICC) and fluorescence in situ hybridization (FISH)) and molecular assays (next generation sequencing (NGS)). The CNSide CSF tumor cell enumeration LDT is currently being used in the ReSPECT-LM trial as an exploratory endpoint and is currently anticipated to become commercially available in 2025.
About Leptomeningeal Metastases (LM)
LM is a rare complication of cancer in which the primary cancer spreads to the cerebrospinal fluid (CSF) and leptomeninges surrounding the brain and spinal cord. All malignancies originating from solid tumors, primary brain tumors, or hematological malignancies have this LM complication potential with breast cancer as the most common cancer linked to LM, with 3-5% of breast cancer patients developing LM. Additionally, lung cancer, GI cancers and melanoma can also spread to the CSF and result in LM. LM occurs in approximately 5% of people with cancer and is usually terminal with 1-year and 2-year survival of just 7% and 3%, respectively. The incidence of LM is on the rise, partly because cancer patients are living longer and partly because many standard chemotherapies cannot reach sufficient concentrations in the spinal fluid to kill the tumor cells, yet there are no FDA-approved therapies specifically for LM patients, who often succumb to this complication within weeks to several months, if untreated.
About Rhenium (186Re) obisbemeda
Rhenium (186Re) obisbemeda is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. Rhenium (186Re) obisbemeda has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. Rhenium (186Re) obisbemeda is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT).
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This presentation contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “potential,” “anticipating,” “planning” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential role of radiotherapeutics, including Rhenium (186Re) Obisbemeda, in addressing challenging diseases, such as Leptomeningeal Metastases, and predicted timeline of commercialization of the CNSide CSF tumor cell enumeration test.
The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: reliance on third parties, including SpectronRx; the early stage of the Company’s product candidates and therapies; the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash to fund its operations in the near term and long term, on terms acceptable to us or at all; the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to the Company, including the ability to come into compliance with The Nasdaq Capital Market listing requirements; market conditions; product performance; litigation or potential litigation; competition within the cancer diagnostics and therapeutics field; ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms; and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2023, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Charles Y. Huang, MBA
Director of Capital Markets and Investor Relations
Office: (202)-209-5751 | Direct (301)-728-7222
mailto://chuang@plustherapeutics.com
Paulness
4週前
NEWS -- Plus Therapeutics and SpectronRx Announce Radiotherapeutic Manufacturing Partnership
Partnership will expand Plus’ capability to meet late-stage clinical and commercial forecasts for Rhenium (186Re) Obisbemeda and reinforce supply chain redundancy
AUSTIN, Texas and INDIANAPOLIS, Nov. 06, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV), a clinical-stage pharmaceutical company developing targeted radiotherapeutics for central nervous system (CNS) cancers, and SpectronRx, a leading radiopharmaceutical contract developer and manufacturer, announced the signing of a Manufacturing Services Agreement (MSA) for the production of Rhenium (186Re) Obisbemeda, an innovative radiotherapy for CNS cancers, including leptomeningeal metastases and recurrent glioblastoma.
“In 2025, we intend to begin late-stage clinical trials and are actively preparing for commercial level product demand, therefore now is the time to expand our supply chain and partner with leading radiopharmaceutical manufacturers such as SpectronRx that can deliver for us and our patients,” said Marc H. Hedrick, M.D., Plus Therapeutics’ President and Chief Executive Officer. “We believe that SpectronRx’s capabilities will significantly reinforce our existing manufacturing partnerships and position us well for the long term.”
Under this strategic partnership, SpectronRx will utilize its state-of-the-art facilities to produce late-stage clinical and commercial supplies of Rhenium (186Re) Obisbemeda. SpectronRx currently has more than 170,000 sq ft of radiopharmaceutical contract development and manufacturing (rCDMO) space and 150 employees across five locations. It provides services to 29 countries, working hand-in-hand with more than 31 pharmaceutical companies to develop and produce life-saving nuclear medicines, including those radiolabeled with 186Re. By joining forces with Plus Therapeutics, SpectronRx aims to further its mission of advancing nuclear medicine.
“We are proud to align with Plus Therapeutics, leveraging our expertise in nuclear medicine manufacturing to support the advancement of Rhenium (186Re) Obisbemeda and increase patient access to this important therapy,” said Anwer Rizvi, President of SpectronRx. "This collaboration underscores our dedication to advancing nuclear medicine and providing patients with high-quality, life-saving radiotherapies. We look forward to supporting Plus Therapeutics' mission to address the unmet needs of CNS cancer patients."
The partnership aims to enhance the supply chain redundancy for Plus Therapeutics and ensure that the demands of late-stage clinical trials and future commercial needs could be met effectively. This agreement marks a crucial step in expanding the reach and impact of Rhenium (186Re) Obisbemeda.
About Rhenium (186Re) Obisbemeda
Rhenium (186Re) Obisbemeda is a novel injectable radiotherapy specifically formulated to deliver direct targeted high-dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. Rhenium (186Re) Obisbemeda has the potential to reduce off-target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. Rhenium (186Re) Obisbemeda is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT).
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
About SpectronRx
SpectronRx is a diagnostic and therapeutic radiopharmaceutical developer and manufacturer with three distinct specialties: Radiopharmaceutical Contract Development (rCDMO), Radiopharmaceutical Contract Manufacturing (rCMO), and Isotope Production. The company performs all scales of development, from initial conjugations through scale-up and commercial distribution. It also has the capacity to run clinical trials. Additionally, SpectronRx's deep industry knowledge, technical prowess and state-of-the-art facilities enable the company to significantly condense the timeline for bringing new medicines to market, which has the dual benefit of saving lives and driving greater profitability for clients.
With a large staff of radiochemists, radiopharmacists, scientists and engineers, dozens of qualified clean rooms, and over 170,000 sq. ft. of production space in Indiana, with additional facilities in Danbury, Connecticut and Europe, SpectronRx now supplies therapeutic and diagnostic radiopharmaceuticals to 29 countries. The company has been EMA and FDA inspected and can produce and procure any currently used radioisotopes. For more information visit https://SpectronRx.com, or follow the company on LinkedIn.
Cautionary Statement Regarding Forward-Looking Statements
This presentation contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “potential,” “intend,” “aim,” “expect,” “believe,” “could” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise and impact of Rhenium (186Re) Obisbemeda; the Company’s clinical trials including statements regarding the timing of late-stage clinical trials and commercial level product demand; expected enhancement of manufacturing capabilities to support late stage clinical trials and preparation for commercial level product demand; ability of SpectronRx to support the development, manufacturing, distribution and operations needs of the Company, including the production of production of Rhenium (186Re) Obisbemeda by SpectronRx; expected expansion of supply chain and partnerships with leading radiopharmaceutical manufacturers; and increased patient access to Rhenium (186Re) Obisbemeda.
The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash to fund its operations in the near term and long term, on terms acceptable to us or at all, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, including the ability to come into compliance with The Nasdaq Capital Market listing requirements, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms, and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2023, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Plus Therapeutics Investor Contact
Charles Y. Huang, MBA
Director of Capital Markets and Investor Relations
Office: (202)-209-5751 | Direct (301)-728-7222
mailto://chuang@plustherapeutics.com
SpectronRx Media Contact
Brian Fitzgerald
mailto://BFitzgerald@SpectronRx.com
(808) 754-0437
Paulness
4週前
NEWS -- Plus Therapeutics to Announce Third Quarter Financial Results and Host Conference Call on November 14, 2024
AUSTIN, Texas, Nov. 05, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced that the Company will report third quarter 2024 financial results on Thursday, November 14, 2024, after market close. Plus Therapeutics’ management team will then host a conference call and webcast at 5:00 p.m. ET to discuss the financial results and provide a corporate update.
Webcast and Conference Call
Date/Time: Thursday, November 14, 2024 @ 5:00 PM ET
Webcast: https://edge.media-server.com/mmc/p/rdthweko
Dial-in Link: https://register.vevent.com/register/BI0e7763782e4d40cebe225238e201e7da
Participants are encouraged to pre-register any time before the call through the dial-in link. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial in 15 minutes prior to the start time.
Following the live call, a replay will be available on the Company’s website under the ‘For Investors’ section. The webcast will be available on the Company’s website for 90 days following the live call.
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of 186Re including the ability of 186Re to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM and ReSPECT-LM clinical trials; possible negative effects of 186Re; the continued evaluation of 186Re including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Charles Y. Huang, MBA
Director of Capital Markets and Investor Relations
Office: (202)-209-5751 | Direct (301)-728-7222
mailto://chuang@plustherapeutics.com
Paulness
2月前
NEWS -- Plus Therapeutics Reports ReSPECT-GBM Clinical Trial Update at the 2024 Congress of Neurological Surgeons Annual Meeting
Rhenium (186Re) Obisbemeda delivered by convection enhanced delivery (CED) continues to show safety, response, and potential efficacy
Mean Phase 2 absorbed dose was 300 Gy and 89% of patients exceeded the minimal dose threshold of 100 Gy
ReSPECT-GBM Phase 1/2 trial has expanded to two new sites at leading U.S. academic medical centers in New York and Upper Midwest
AUSTIN, Texas, Oct. 01, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers presented an update on the ongoing ReSPECT-GBM Phase 1/2 clinical trial, evaluating the Company’s lead asset Rhenium (186Re) Obisbemeda for the treatment of recurrent glioblastoma. The data were presented at the 2024 Congress of Neurological Surgeons (CNS) Annual Meeting on September 30, 2024, in Houston, Texas.
The presentation, titled “Treatment of Recurrent Glioblastoma (rGBM) via Convection Enhanced Delivery (CED) with Rhenium (186Re) Obisbemeda (Rhenium-186 Nanoliposome, 186RNL): ReSPECT-GBM Phase 1/2 Trial Update” was delivered by lead investigator and neurosurgeon John Floyd, M.D., Associate Professor and Chair of the Department of Neurosurgery at the University of Texas Health Science Center San Antonio. The data highlights the continued favorable safety profile and encouraging efficacy results of Rhenium (186Re) Obisbemeda in a patient population with historically poor prognosis.
“The ReSPECT-GBM Phase 1/2 trial continues to reinforce the safety signal and potential efficacy of Rhenium (186Re) Obisbemeda in patients with recurrent glioblastoma,” said John Floyd, M.D. “These updated results, particularly the encouraging safety profile and overall survival rates, support the advancement of Rhenium (186Re) Obisbemeda as a promising therapeutic option for this aggressive cancer, and we are currently open and enrolling in our Phase 2 study.”
ReSPECT-GBM is a first-in-human, open-label, Phase 1/2 study investigating feasibility, dose escalation, and critical convection enhanced delivery (CED) parameters to determine the maximum tolerated dose (MTD), maximum feasible dose (MFD), safety, and potential efficacy of Rhenium (186Re) Obisbemeda in recurrent adult glioma (IND 116117).
Key Highlights from the ReSPECT-GBM Phase 1/2 Trial Update:
42 total patients have enrolled thus far at 3 sites and with 19/42 patients having been treated to date at the recommended Phase 2 dose (22.3 mCi in 8.8 mL) in tumors of approximately 20 cm3 or lessAll Phase 2 patients have recurrent, histologically confirmed glioblastoma; 1 recurrence, bevacizumab naïve, single tumor of approximately 20 cm3 or less (small-to-medium sized tumors)Average tumor size in Phase 2 was 7.5 mL (range 0.9-22.8 mL)Increases in absorbed dose correlated with specific drug delivery parameters such as infused dose and volume, maximal convection flow rate, and number of cathetersRhenium (186Re) Obisbemeda continues to show a favorable safety profile in the 42 enrolled patients; one dose-limiting toxicity (hemiplegia) has been reported, which was observed in Cohort 8 (41.5 mCi and 16.3 mL)In Phase 2, most adverse events (AEs) were mild (73.5%) or moderate (18.8%), and largely unrelated (37.7%), or unlikely related (27.1%) to the drug. Of the 9 severe adverse events (SAEs), only 2 were related to the study drugAverage absorbed radiation dose to the tumor in Phase 2 was 300 Gy (n=18, 1 patient still under analysis)To date, 88.9% of Phase 2 patients met key CED drug delivery parameters shown to correlate with overall survival, achieving a tumor absorbed dose >100 Gy and radiation coverage of >70%29/42 patients treated thus far participated in the Phase 1 dose escalation phase of the trial (Note: as per protocol, 6/42 patients were included in both the Phase 1 and Phase 2 trial arms and related analyses)Phase 1 dose-escalation increased administered doses from 1.0 mCi to 41.5 mCi and volumes from 0.66 mL to 16.3 mLIn terms of objective tumor response based on quantitative image analysis, a statistically significant reduction in tumor volume rate change was seen in tumors receiving > 100 Gy absorbed dose (n=11 patients analyzed to date, p<0.005). Sufficient tumor coverage correlated with tumor control, while regrowth occurred outside treated areas"As presented at CNS by Dr. Floyd, who has helped pioneer this therapy, the ReSPECT-GBM trial continues to show promising feasibility, safety, response, and potential efficacy," said Marc H. Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer. "Furthermore, the addition of new clinical trial sites, including North Shore University in New York and Ohio State University in the Upper Midwest, should help us complete both the Phase 1 and Phase 2 arms in the near term."
Full details of the presentation can be found here.
The ReSPECT-GBM trial is actively enrolling patients; additional information about the ReSPECT-GBM trial can be found here.
About Glioblastoma (GBM)
GBM affects approximately 15,000 patients annually in the U.S. and is the most common and lethal form of brain cancer. The average life expectancy with GBM is less than 24 months, with a one-year survival rate of 40% and a five-year survival rate of around 5%. There is no clear standard of care for recurrent GBM, and the few currently approved treatments provide only marginal survival benefit and are associated with significant side effects, which limit dosing and prolonged use. Approximately 90% of patients experience GBM tumor recurrence at or near the original tumor location, yet there are no FDA-approved treatments in the recurrent or progressive setting that can significantly extend a patient’s life.
About Rhenium (186Re) Obisbemeda
Rhenium (186Re) Obisbemeda is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. Rhenium (186Re) Obisbemeda has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. Rhenium (186Re) Obisbemeda is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT).
About Convection Enhanced Delivery
Convection Enhanced Delivery (CED) is a therapeutic strategy that was developed to facilitate targeted delivery of pharmaceuticals to the brain. The CED procedure involves a minimally invasive surgical exposure of the brain, followed by placement of small diameter catheters directly into the brain tumor.
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This presentation contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “potential,” “anticipating,” “planning” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of Rhenium (186Re) Obisbemeda including the ability of Rhenium (186Re) Obisbemeda to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM, ReSPECT-LM and ReSPECT-PBC, clinical trials; possible negative effects of Rhenium (186Re) Obisbemeda; the continued evaluation of Rhenium (186Re) Obisbemeda including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms, and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2023, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Charles Y. Huang, MBA
Director of Capital Markets and Investor Relations
Office: (202)-209-5751 | Direct (301)-728-7222
mailto://chuang@plustherapeutics.com
Paulness
3月前
NEWS -- Plus Therapeutics Showcases New Interim ReSPECT-GBM Phase 2 Trial Data at the 2024 Congress of Neurological Surgeons Annual Meeting
Company to present new data, highlighting progress in its therapeutics program for recurrent glioblastoma (rGBM)
AUSTIN, Texas, Sept. 18, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, will present data at the 2024 Congress of Neurological Surgeons (CNS) Annual Meeting September 28 - October 2, in Houston, Texas.
Presentation:
Title Treatment of Recurrent Glioblastoma (rGBM) via Convection Enhanced Delivery (CED) with Rhenium (186Re) Obisbemeda (Rhenium-186 Nanoliposome, 186RNL): ReSPECT-GBM Phase 2 Trial Update
Presenter John Floyd, M.D., Associate Professor and Chairman Neurosurgery, UT Health Science San Antonio
Date/Time Monday, 30 September 2024, 7:00-08:30 a.m. CDT
Location George R. Brown Convention Center, Room 310C
About Recurrent Glioblastoma (GBM)
GBM affects approximately 15,000 patients annually in the U.S. and is the most common and lethal form of brain cancer. The average life expectancy with GBM is less than 24 months, with a one-year survival rate of 40% and a five-year survival rate of around 5%. There is no clear standard of care for recurrent GBM and the few currently approved treatments provide only marginal survival benefit and are associated with significant side effects, which limit dosing and prolonged use. Approximately 90% of patients experience GBM tumor recurrence at or near the original tumor location, yet there are no FDA-approved treatments in the recurrent or progressive setting that can significantly extend a patient’s life.
About Rhenium (186Re) Obisbemeda
Rhenium (186Re) Obisbemeda is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. Rhenium (186Re) Obisbemeda has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. Rhenium (186Re) Obisbemeda is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT).
About Convection-Enhanced Delivery
Convection Enhanced Delivery (CED) is a therapeutic strategy that was developed to facilitate targeted delivery of pharmaceuticals to the brain. The CED procedure involves a minimally invasive surgical exposure of the brain, followed by placement of small diameter catheters directly into the brain tumor.
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This presentation contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “potential,” “anticipating,” “planning” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of Rhenium (186Re) Obisbemeda including the ability of Rhenium (186Re) Obisbemeda to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM, ReSPECT-LM and ReSPECT-PBC, clinical trials; possible negative effects of Rhenium (186Re) Obisbemeda; the continued evaluation of Rhenium (186Re) Obisbemeda including through evaluations in additional patient cohorts; the intended functions of the Company’s platform and expected benefits from such functions; and the development, utility and potential of the CNSide leptomeningeal metastases diagnostic test.
The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms, and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2023, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Charles Y. Huang, MBA
Director of Capital Markets and Investor Relations
Office: (202)-209-5751 | Direct (301)-728-7222
mailto://chuang@plustherapeutics.com
Paulness
3月前
NEWS -- Plus Therapeutics to Present at the H.C. Wainwright 26th Annual Global Investment Conference
AUSTIN, Texas, Sept. 04, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announced that Marc H. Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer will present a corporate overview at the H.C. Wainwright 26th Annual Global Investment Conference. The conference is being held on September 9 – 11, 2024 at the Lotte New York Palace Hotel.
Presentation Time: Monday, September 9, 2024, available on-demand starting at 7:00 AM ET
Webcast Link: Here
A replay of this presentation will be available for 90 days following the date of the presentation on the Company’s website at: https://ir.plustherapeutics.com/events
Management will be available for one-on-one meetings at the conference. To request a meeting and to register for the conference, click here: https://hcwevents.com/annualconference/
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This presentation contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “potential,” “anticipating,” “planning” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of Rhenium (186Re) Obisbemeda including the ability of Rhenium (186Re) Obisbemeda to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM, ReSPECT-LM and ReSPECT-PBC, clinical trials; possible negative effects of Rhenium (186Re) Obisbemeda; the continued evaluation of Rhenium (186Re) Obisbemeda including through evaluations in additional patient cohorts; the intended functions of the Company’s platform and expected benefits from such functions; and the development, utility and potential of the CNSide leptomeningeal metastases diagnostic test.
The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms, and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2023, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Charles Y. Huang, MBA
Director of Capital Markets and Investor Relations
Office: (202)-209-5751 | Direct (301)-728-7222
mailto://chuang@plustherapeutics.com
Paulness
4月前
NEWS -- Plus Therapeutics Presents Positive Clinical Trial Results at the 2024 SNO/ASCO CNS Metastases Conference
Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, presented data from the FORESEE study of its CNSide platform for the diagnosis and management of LM. The data were presented in a podium presentation at the 2024 Society for NeuroOncology (SNO)/American Society for Clinical Oncology (ASCO) CNS Metastases Conference August 8-10, 2024 in Denver, Colorado.
The study, titled “A Therapy Treatment Response Trial in Patients with Leptomeningeal Metastases (LM) Using CNSide (FORESEE Study, NCT05414123),” was a prospective, multi-center observational trial enrolling 39 patients with Breast (21 patients) or Non-Small Cell Lung Cancer (18 patients) with a suspected or confirmed diagnosis of LM. The primary endpoint of the study assessed how CNSide test results influenced clinical decision-making. Secondary endpoints assessed CNSide vs. the gold standard of LM diagnosis, CSF cytology, and its use for personalization of treatment selection based on tumor molecular phenotype. The study was presented by Priya U. Kumthekar, M.D., Associate Professor of Neurology and Medicine at Northwestern University and FORSEE Trial Principal Investigator.
Key results from the FORESEE trial:
The trial achieved its primary endpoint, demonstrating that CNSide influenced treatment decisions in over 90% of cases, surpassing the 20% primary endpoint targetCNSide demonstrated enhanced sensitivity in detecting tumor cells (80%) vs. cytology (29%) in patients with LMCNSide identified actionable mutations in the CSF, such as HER2 amplification, influencing 24% of therapeutic selection decisionsCNSide exhibited high specificity, with no tumor cells detected in patients without LM“The FORESEE trial met its key primary and secondary endpoints, objectively showing that CNSide has very high clinical utility for treating physicians,” said Priya U. Kumthekar, M.D., “CNSide is a more sensitive and definitive test for LM and has the potential to permit earlier diagnosis, manage our patients with more diagnostic precision, and hopefully improve therapeutic outcomes for our patients with LM.”
About CNSide Test
CNSide is a laboratory developed test (LDT) based on proprietary quantitative tumor cell capture and detection method, paired with assays to identify actionable molecular treatment targets. Given the genetic changes that can occur as metastatic cancer spreads to the CNS, the evaluation of cerebrospinal fluid with CNSide provides a unique opportunity to identify biomarkers in patients with metastatic carcinoma or melanoma to help guide physicians in therapy selection. In addition, the quantitative tumor cell count assay is designed to be used in a serial fashion to monitor the response to therapy more effectively than other current methods. CNSide is currently being used in the ReSPECT-LM trial to quantify circulating tumor cells (CTCs) as an exploratory endpoint.
About Leptomeningeal Metastases (LM)
LM is a rare complication of cancer in which the primary cancer spreads to the cerebrospinal fluid (CSF) and leptomeninges surrounding the brain and spinal cord. All malignancies originating from solid tumors, primary brain tumors, or hematological malignancies have this LM complication potential with breast cancer as the most common cancer linked to LM, with 3-5% of breast cancer patients developing LM. Additionally, lung cancer, GI cancers and melanoma can also spread to the CSF and result in LM. LM occurs in approximately 5% of people with cancer and is usually terminal with 1-year and 2-year survival of just 7% and 3%, respectively. The incidence of LM is on the rise, partly because cancer patients are living longer and partly because many standard chemotherapies cannot reach sufficient concentrations in the spinal fluid to kill the tumor cells, yet there are no FDA-approved therapies specifically for LM patients, who often succumb to this complication within weeks to several months, if untreated.
About Rhenium (186Re) obisbemeda
Rhenium (186Re) obisbemeda is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. Rhenium (186Re) obisbemeda has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. Rhenium (186Re) obisbemeda is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT).
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This presentation contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “potential,” “anticipating,” “planning” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of Rhenium (186Re) Obisbemeda including the ability of Rhenium (186Re) Obisbemeda to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM, ReSPECT-LM and ReSPECT-PBC, clinical trials; possible negative effects of Rhenium (186Re) Obisbemeda; the continued evaluation of Rhenium (186Re) Obisbemeda including through evaluations in additional patient cohorts; the intended functions of the Company’s platform and expected benefits from such functions; and the development, utility and potential of the CNSide leptomeningeal metastases diagnostic test.
The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms, and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2023, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Charles Y. Huang, MBA
Director of Capital Markets and Investor Relations
Office: (202)-209-5751 | Direct (301)-728-7222
mailto://chuang@plustherapeutics.com
Paulness
4月前
NEWS -- Plus Therapeutics Presents Positive Interim ReSPECT-LM Phase 1 Data for Leptomeningeal Metastases at 2024 SNO/ASCO CNS Metastases Conference
Respect-LM dosing shows continued feasibility and safety of up to 44 mCi of intrathecal Rhenium (186Re) Obisbemeda
High absorbed radiation doses, mean circulating tumor cell reductions, and median overall survival of 12 months continue to show clinical promise
AUSTIN, Texas, Aug. 12, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, presented data in a podium presentation updating the progress of its ReSPECT-LM clinical trial of Rhenium (186Re) Obisbemeda (Rhenium Nanoliposome, 186RNL) in leptomeningeal disease (LM). The data were presented at the 2024 Society for NeuroOncology (SNO)/American Society for Clinical Oncology (ASCO) CNS Metastases Conference August 8-10, 2024 in Denver, Colorado.
The presentation, titled, “Phase 1 Dose Escalation of Rhenium (186Re) Obisbemeda (Rhenium Nanoliposome, 186RNL) for the Treatment of Leptomeningeal Metastases (LM): Ongoing Clinical Study Update for Initial Safety and Feasibility,” provided a safety and efficacy update on the single dose trial for the first 4 cohorts (n = 16 patients). The trial is currently enrolling in Cohort 5. The study was presented by Andrew Brenner, M.D., Ph.D., Professor and Kolitz/Zachry Endowed Chair Neuro-Oncology Research; Co-Leader, Experimental and Developmental Therapeutics Program, University of Texas Health, San Antonio.
Key ReSPECT-LM highlights through Cohort 4:
16 patients were treated: 8 patients had a breast cancer primary diagnosis, 4 patients had a lung cancer primary diagnosis, and 4 patients had a mix of other primary cancersThere were no dose limiting toxicities through cohort 4 and the maximum tolerated dose or maximum feasible dose was not reachedWe observed a linear increase in absorbed radiation dose to the spinal fluid and ventricles and cranial subarachnoid space over 4 cohortsIn cohort 4, the mean average absorbed radiation dose to the ventricles and cranial subarachnoid space was 156 Gy vs. 1 Gy to the spleenThe majority of adverse events (AEs) across all 4 cohorts were mild or moderate and unrelated or unlikely related to the study drugThere was a mean reduction of CSF circulating tumor cells (CTCs) of 53% at 28 days post treatment vs. baseline (CTCs only performed on only Cohorts 1-3 as testing was commercially unavailable during Cohort 4)Median overall survival for Cohorts 1-4 was 12 months with 8 of 16 patients alive at the time of analysis“The ReSPECT-LM Phase 1 dose escalation study continues to show feasibility, safety, and a response in circulating tumor cells in LM patients treated with Rhenium (186Re) Obisbemeda,” said Dr. Andrew Brenner, M.D., Ph.D., “Furthermore, a median overall survival rate of 12 months is very encouraging and is consistent with the high doses of absorbed radiation delivered and the mean circulating tumor cell reduction we have observed.”
The FDA has granted Fast Track designation to Rhenium (186Re) Obisbemeda for the treatment of LM. The FDA has also granted Orphan Drug designation to Rhenium (186Re) Obisbemeda for the treatment of LM in breast cancer patients.
The ReSPECT-LM clinical trial is funded in part, by a 3-year, $17.6 million grant by the Cancer Prevention & Research Institute of Texas. Additional information about the ReSPECT-LM trial can be found here.
About Leptomeningeal Metastases (LM)
LM is a rare complication of cancer in which the primary cancer spreads to the cerebrospinal fluid (CSF) and leptomeninges surrounding the brain and spinal cord. All malignancies originating from solid tumors, primary brain tumors, or hematological malignancies have this LM complication potential with breast cancer as the most common cancer linked to LM, with 3-5% of breast cancer patients developing LM. Additionally, lung cancer, GI cancers and melanoma can also spread to the CSF and result in LM. LM occurs in approximately 5% of people with cancer and is usually terminal with 1-year and 2-year survival of just 7% and 3%, respectively. The incidence of LM is on the rise, partly because cancer patients are living longer and partly because many standard chemotherapies cannot reach sufficient concentrations in the spinal fluid to kill the tumor cells, yet there are no FDA-approved therapies specifically for LM patients, who often succumb to this complication within weeks to several months, if untreated.
About Rhenium (186Re) Obisbemeda
Rhenium (186Re) Obisbemeda is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. Rhenium (186Re) Obisbemeda has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. Rhenium (186Re) Obisbemeda is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT).
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
About the Cancer Prevention & Research Institute of Texas (CPRIT)
CPRIT was created by the Texas Legislature and approved by a statewide vote in 2007 to lead the Lone Star State’s fight against cancer. In 2019, Texas voters again voted overwhelmingly to continue CPRIT with an additional $3 billion for a total $6 billion investment in cancer research and prevention.
To date, CPRIT has awarded over $3 billion in grants to Texas research institutions and organizations through its academic research, prevention and product development research programs. CPRIT has recruited 281 distinguished researchers, supported the establishment, expansion or relocation of 52 companies to Texas and generated over $7.66 billion in additional public and private investment. CPRIT funding has advanced scientific and clinical knowledge and provided 8.2 million life-saving cancer prevention and early detection services reaching Texans from all 254 counties. Learn more at https://cprit.texas.gov/about-us
Cautionary Statement Regarding Forward-Looking Statements
This presentation contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “potential,” “anticipating,” “planning” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of Rhenium (186Re) Obisbemeda including the ability of Rhenium (186Re) Obisbemeda to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM, ReSPECT-LM and ReSPECT-PBC, clinical trials; possible negative effects of Rhenium (186Re) Obisbemeda; the continued evaluation of Rhenium (186Re) Obisbemeda including through evaluations in additional patient cohorts; the intended functions of the Company’s platform and expected benefits from such functions; and the development, utility and potential of the CNSide leptomeningeal metastases diagnostic test.
The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms, and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2023, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Charles Y. Huang, MBA
Director of Capital Markets and Investor Relations
Office: (202)-209-5751 | Direct (301)-728-7222
mailto://chuang@plustherapeutics.com
Paulness
4月前
NEWS -- Plus Therapeutics to Announce Second Quarter Financial Results and Host Conference Call on August 14, 2024
AUSTIN, Texas, Aug. 08, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced that the Company will report second quarter 2024 financial results on Wednesday, August 14, 2024, after market close. Plus Therapeutics’ management team will then host a conference call and webcast at 5:00 p.m. ET to discuss the financial results and provide a corporate update.
Webcast and Conference Call
Date/Time: Wednesday, August 14, 2024 @ 5:00 PM ET
Webcast: https://edge.media-server.com/mmc/p/mtnrwhh5
Dial-in Link: https://register.vevent.com/register/BI1c575c6aa37840b9872f3ad10091195c
Participants are encouraged to pre-register any time before the call through the dial-in link. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial in 15 minutes prior to the start time.
Following the live call, a replay will be available on the Company’s website under the ‘For Investors’ section. The webcast will be available on the Company’s website for 90 days following the live call.
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a robust supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of 186Re including the ability of 186Re to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM and ReSPECT-LM clinical trials; possible negative effects of 186Re; the continued evaluation of 186Re including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Charles Y. Huang, MBA
Director of Capital Markets and Investor Relations
Office: (202)-209-5751 | Direct (301)-728-7222
mailto://chuang@plustherapeutics.com
Paulness
4月前
NEWS -- Plus Therapeutics Showcases Leptomeningeal Metastases Programs at 2024 SNO/ASCO Conference
Company to present new data, highlighting progress in its therapeutics and diagnostics programs for Leptomeningeal Metastases
AUSTIN, Texas, July 25, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, will have multiple opportunities to present data at the 2024 Society for Neuro-Oncology (SNO) / American Society for Clinical Oncology (ASCO) CNS Metastases Conference August 8-10, in Denver, Colorado.
“This year’s SNO/ASCO Metastases conference is a key opportunity for Plus to highlight advancements in our LM therapeutics and diagnostics programs,” said Marc H. Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer. “The conference gathers key influencers and clinicians to discuss important topics in the field and we are honored to have multiple opportunities to share our results with the scientific community.”
Events and data presentations include:
Symposium:
The Company will be hosting a symposium titled, “Emerging Novel Diagnostic and Therapeutic Approaches for Leptomeningeal Metastases” on August 8, 2024, at 6:15-7:15 p.m. MDT in the Plaza Ballroom (DEF) of the Sheraton Denver Downtown Hotel. Speakers include:
Greg Fuller, M.D., Ph.D., Plus Therapeutics Medical Director and VP of Medical Affairs; Former Chief, Section of Neuropathology, The University of Texas MD Anderson Cancer Center
Seema Nagpal, M.D., Clinical Professor, Neurology & Neurological Sciences, Stanford University
Jonathan Yang, M.D., Ph.D., Associate Vice Chair for Clinical Research and Developmental Therapeutics, Department of Radiation Oncology, Director of Clinical Research, NYU Langone Health’s Perlmutter Cancer Center
Andrew Brenner, M.D., Ph.D., Professor and Kolitz / Zachry Endowed Chair Neuro-Oncology Research; Co-Leader, Experimental and Developmental Therapeutics Program, University of Texas Health, Science Center at San AntonioTherapeutic:
Presentation:
Title: Phase 1 Dose Escalation of Rhenium (186Re) Obisbemeda (Rhenium Nanoliposome,186RNL) for the Treatment of Leptomeningeal Metastases (LM): Ongoing Clinical Study Update for Initial Safety and Feasibility), OCTS-11
Presenter: Andrew Brenner, M.D., Ph.D.
Date/Time: Friday, 09 August 2024, 1:10-2:30 p.m. MDT
Location: Plaza Ballroom (ABC)Poster:
Title: Radiation Absorbed Dose to Spinal Cord: Therapy of Leptomeningeal Metastases Using Beta-Emission Radiopharmaceuticals, RMTD-08
Presenter: Ande Bao, Ph.D., M.S., Assistant Professor, Department of Radiation Oncology, School of Medicine at Case Western University
Date/Time: Thursday, 08 August 2024, 7:15-09:00 p.m. MDT
Location: Plaza Exhibit HallDiagnostic:
Presentation:
Title: CSF Tumor Cell (CSF-TC) Detection, Quantification and Biomarker assessment helps in clinical management of breast cancer and Non-Small Cell Lung cancer patients having Leptomeningeal Disease (FORESEE Study, NCT05414123), BMRK-13
Presenter: Priya Kumthekar, M.D., Associate Professor of Neurology and Hematology/Oncology, Northwestern University Medical School
Date/Time: Saturday, 10 August 2024, 08:45-10:05 a.m. MDT
Location: Plaza Ballroom (ABC)Poster:
Title: The CNSide CSF Tumor Cell detection platform is a feasible, clinically relevant and scalable platform for disease management for patients with Leptomeningeal Disease, BMRK-12
Presenter: Arushi Tripathy, M.D., Neurosurgery PGY-4 Resident at University of Michigan Medical School
Date/Time: Thursday, 08 August 2024, 7:15-9:00 p.m. MDT
Location: Plaza Exhibit HallAbout Leptomeningeal Metastases (LM)
LM is a rare complication of cancer in which the primary cancer spreads to the cerebrospinal fluid (CSF) and leptomeninges surrounding the brain and spinal cord. All malignancies originating from solid tumors, primary brain tumors, or hematological malignancies have this LM complication potential with breast cancer as the most common cancer linked to LM, with 3-5% of breast cancer patients developing LM. Additionally, lung cancer, GI cancers and melanoma can also spread to the CSF and result in LM. LM occurs in approximately 5% of people with cancer and is usually terminal with 1-year and 2-year survival of just 7% and 3%, respectively. The incidence of LM is on the rise, partly because cancer patients are living longer and partly because many standard chemotherapies cannot reach sufficient concentrations in the spinal fluid to kill the tumor cells, yet there are no FDA-approved therapies specifically for LM patients, who often succumb to this complication within weeks to several months, if untreated.
About Rhenium (186Re) obisbemeda
Rhenium (186Re) obisbemeda is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. Rhenium (186Re) obisbemeda has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. Rhenium (186Re) obisbemeda is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT).
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
About CNSide Test
CNSide is a laboratory developed test (LDT) based on proprietary quantitative tumor cell capture and detection method, paired with assays to identify actionable molecular treatment targets. Given the genetic changes that can occur as metastatic cancer spreads to the CNS, the evaluation of cerebrospinal fluid with CNSide provides a unique opportunity to identify biomarkers in patients with metastatic carcinoma or melanoma to help guide physicians in therapy selection. In addition, the quantitative tumor cell count assay is designed to be used in a serial fashion to monitor the response to therapy more effectively than other current methods.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “potential,” “anticipating,” “planning” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of rhenium (186Re) obisbemeda including the ability of rhenium (186Re) obisbemeda to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM, ReSPECT-LM and ReSPECT-PBC and increase of ten o, clinical trials; possible negative effects of rhenium (186Re) obisbemeda; the continued evaluation of rhenium (186Re) obisbemeda including through evaluations in additional patient cohorts; development and utility of CNSide leptomeningeal metastases diagnostic test; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms, and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2023, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Charles Y. Huang, MBA
Director of Capital Markets and Investor Relations
Office: (202)-209-5751 | Direct (301)-728-7222
mailto://chuang@plustherapeutics.com
Paulness
6月前
NEWS -- Plus Therapeutics Expands Management Team and Reports $3.3M Advance Payment from CPRIT
Greg Fuller, M.D., Ph.D., former Professor of Pathology (Neuro-Pathology) & Neuro-Radiology at The University of Texas MD Anderson Cancer Center joins Plus as Vice President of Medical Affairs and Medical Director
Plus receives notice of an additional $3.3 million CPRIT advance payment for leptomeningeal cancer targeted radiotherapeutic development program
AUSTIN, Texas, June 07, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, announced the appointment of Dr. Greg Fuller as the Company’s Vice President of Medical Affairs and Medical Director. Additionally, the Company received notice of an advance payment of $3.3 million from CPRIT, part of the $17.6 million award granted in September 2022.
Dr. Fuller will help lead the implementation of the recently acquired CNSide® cerebrospinal fluid cancer diagnostic portfolio, ensuring its successful transition to commercial use under the current Laboratory Developed Test (LDT) requirements. Currently utilized in the CPRIT-funded ReSPECT-LM clinical trial, CNSide is on track for commercial launch as soon as Q4 2024. Next-generation diagnostic testing, such as CNSide, is vital for improving patient care for leptomeningeal metastases (LM) and advancing the Company’s broader LM program for several reasons:
Recently published data indicated that CNSide is over 90% sensitive for detecting LM, significantly outperforming MRI and cytology
Autopsy studies suggested LM incidence is underdiagnosed by 2-4 times and the increased diagnostic sensitivity of CNSide could expand the total addressable market for the Company’s lead radiotherapeutic candidate rhenium (Re186) obisbemeda
CNSide potentially addresses a total commercial market of over 500,000 tests annually
The CNSide test demonstrated clinical utility in 40 patients with LM from breast or non-small cell lung cancer in the FORESEE trial; a presentation of the full analysis is planned for the SNO/ASCO Meeting in Denver, Colorado, on August 8-10“I am excited to join the Plus team and to dedicate my expertise to accelerating the adoption of CNSide in a clinical and commercial setting,” said Greg Fuller, M.D., Ph.D. “Driving the availability of this testing to our patients is imperative, especially given the complexities of treating LM.”
Furthermore, the Company also received notice of a $3.3 million advance grant payment from CPRIT in June 2024. This funding supports the clinical development of rhenium (Re186) obisbemeda for LM as well as CNSide testing in the RePSECT-LM trial. In addition to determining the safety and potential efficacy of rhenium (Re186) obisbemeda for LM, data gathered from the RePSECT-LM trial will further validate CNSide's clinical utility and support commercialization. An update on enrollment and safety data from the ReSPECT-LM trial is planned for the August SNO/ASCO Meeting in Denver.
New Employment Inducement Grants
In connection with Dr. Fuller’s hire, on June 6, 2024, the Company granted option awards to Dr. Fuller to purchase up to 13,116 shares of the common stock of the Company. The Company agreed to grant these option awards as an inducement of Dr. Fuller commencing employment with the Company. The options are scheduled to vest over four years, with one-fourth of the options vesting on the first anniversary of the grant date with the remaining options vesting thereafter in equal monthly installments. The vesting of the options is also subject to certain requirements, including Dr. Fuller’s continued service as an employee of the Company through the applicable vesting dates. The exercise price of the options is equal to the closing price of the Company’s common stock on June 6, 2024, the grant date.
The Company believes that these equity grants create a strong alignment of interests between Dr. Fuller and Company shareholders. The equity awards were granted with terms and conditions consistent with the Company’s 2015 New Employee Incentive Plan.
About Leptomeningeal Metastases (LM)
LM is a rare complication of cancer in which the primary cancer spreads to the cerebrospinal fluid (CSF) and leptomeninges surrounding the brain and spinal cord. All malignancies originating from solid tumors, primary brain tumors, or hematological malignancies have this LM complication potential. Although breast cancer is the most common cancer linked to LM, with ~10-15% of all breast cancer patients developing LM (and ~25% for inflammatory breast cancer), lung cancer, GI cancers, and melanoma can also spread to the CSF and have high LM risk. LM occurs in approximately 5% of all people with cancer and is usually terminal with 1-year and 2-year survival of just 7% and 3%, respectively. The incidence of LM is on the rise, partly because cancer patients are living longer and partly because many standard chemotherapies cannot reach sufficient concentrations in the spinal fluid to kill the tumor cells, yet there are no FDA-approved therapies specifically for LM patients, who often succumb to this complication within weeks to several months, if untreated.
About Rhenium (186Re) obisbemeda
Rhenium (186Re) obisbemeda is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. Rhenium (186Re) obisbemeda has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. Rhenium (186Re) obisbemeda is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT).
About CNSide Test
CNSide is a laboratory developed test (LDT) based on proprietary quantitative tumor cell capture and detection method, paired with assays to identify actionable molecular treatment targets. Given the genetic changes that can occur as metastatic cancer spreads to the CNS, the evaluation of cerebrospinal fluid with CNSide provides a unique opportunity to identify biomarkers in patients with metastatic carcinoma or melanoma to help guide physicians in therapy selection. In addition, the quantitative tumor cell count assay is designed to be used in a serial fashion to monitor the response to therapy more effectively than other current methods.
About the Cancer Prevention & Research Institute of Texas (CPRIT)
CPRIT was created by the Texas Legislature and approved by a statewide vote in 2007 to lead the Lone Star State’s fight against cancer. In 2019, Texas voters again voted overwhelmingly to continue CPRIT with an additional $3 billion for a total $6 billion investment in cancer research and prevention.
To date, CPRIT has awarded over $3 billion in grants to Texas research institutions and organizations through its academic research, prevention and product development research programs. CPRIT has recruited 281 distinguished researchers, supported the establishment, expansion or relocation of 52 companies to Texas and generated over $7.66 billion in additional public and private investment. CPRIT funding has advanced scientific and clinical knowledge and provided 8.2 million life-saving cancer prevention and early detection services reaching Texans from all 254 counties. Learn more at https://cprit.texas.gov/about-us
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This presentation contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “potential,” “anticipating,” “planning” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of rhenium (186Re) obisbemeda including the ability of rhenium (186Re) obisbemeda to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM, ReSPECT-LM and ReSPECT-PBC, clinical trials; possible negative effects of rhenium (186Re) obisbemeda; the continued evaluation of rhenium (186Re) obisbemeda including through evaluations in additional patient cohorts; the intended functions of the Company’s platform and expected benefits from such functions; and the development, utility and potential of the CNSide leptomeningeal metastases diagnostic test.
The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms, and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2023, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Charles Y. Huang, MBA
Director of Capital Markets and Investor Relations
Office: (202)-209-5751 | Direct (301)-728-7222
mailto://chuang@plustherapeutics.com
Paulness
7月前
NEWS -- Plus Therapeutics to Announce First Quarter Financial Results and Host Conference Call on May 15, 2024
AUSTIN, Texas, May 13, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced that the Company will report first quarter 2024 financial results on Wednesday, May 15, 2024, after market close. Plus Therapeutics’ management team will then host a conference call and webcast at 5:00 p.m. ET to discuss the financial results and provide a corporate update.
Webcast and Conference Call
Time: Wednesday, May 15, 2024 @ 5:00 PM ET
Dial-in Link: https://register.vevent.com/register/BI7282c3e944b0498483eb5b57757ccaad
Webcast: https://edge.media-server.com/mmc/p/uaxeqwjm
Participants are encouraged to pre-register any time before the call through the dial-in link. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial in 15 minutes prior to the start time.
Following the live call, a replay will be available on the Company’s website under the ‘For Investors’ section. The webcast will be available on the Company’s website for 90 days following the live call.
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a robust supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of 186Re including the ability of 186Re to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM and ReSPECT-LM clinical trials; possible negative effects of 186Re; the continued evaluation of 186Re including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Charles Y. Huang, MBA
Director of Capital Markets and Investor Relations
Office: (202)-209-5751 | Direct (301)-728-7222
mailto://chuang@plustherapeutics.com
Paulness
7月前
NEWS -- Plus Therapeutics to Host Investor Call to Discuss Leptomeningeal Cancer Related Acquisition and Topline Clinical Trial Data from the FORESEE Trial
Company acquired all assets for the synergistic CNSide cerebrospinal fluid diagnostic portfolio
Company will summarize topline data from the FORESEE clinical trial planned for presentation at the
SNO/ASCO Meeting in August 2024
Management call scheduled for Thursday, May 9th, 2024 at 8:30 AM ET
AUSTIN, Texas, May 08, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announces it will host an investor call on Thursday, May 9th, 2024 at 8:30 AM ET to discuss the strategic acquisition of the CNSide cerebrospinal fluid (CSF) testing assets.
During the call, President and Chief Executive Officer Dr. Marc H. Hedrick will discuss the rationale for the CNSide acquisition and an overview of the assets acquired. In addition, he will also provide key updates since the September 2023 sublicense of CNSide, including topline data from the FORESEE trial, subsequent publications, interim milestones, the Company's business plan to leverage the acquired assets and planned future milestones.
Conference Call and Webcast
Thursday, May 9, 2024 @ 8:30 AM ET
Dial-in Link: https://register.vevent.com/register/BIdc75c8a5a88c41c683b270235002d285
Webcast: https://edge.media-server.com/mmc/p/nor9kmxs
Participants may also pre-register any time before the call through the dial-in-link. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial in 15 minutes prior to the start time.
Following the live call, a replay will be available on the Company’s website under the “For Investors” section. The webcast will be available on the Company’s website for 90 days following the live call.
About CNSide Test
CNSide is a laboratory developed test (LDT) based on proprietary quantitative tumor cell capture and detection method, paired with assays to identify actionable molecular treatment targets. Given the genetic changes that can occur as metastatic cancer spreads to the CNS, the evaluation of cerebrospinal fluid with CNSide provides a unique opportunity to identify biomarkers in patients with metastatic carcinoma or melanoma to help guide physicians in therapy selection. In addition, the quantitative tumor cell count assay can be used in a serial fashion to monitor the response to therapy more effectively than other current methods.
About FORESEE clinical trial
The FORESEE Study is a multi-center, prospective clinical trial enrolling patients with Breast or Non-Small Cell Lung Cancer (NSCLC) who have suspicious or confirmed Leptomeningeal Metastases (LM). Standard of Care methods to diagnose or assess the treatment response of LM (Clinical Evaluation, MRI and Cytology) have limited sensitivity and specificity. This creates challenges for physicians to manage LM or determine the best course of treatment. The goal of the FORESEE Study is to evaluate the performance of CNSide in monitoring the LM's response to treatment and to assess the impact of CNSide on treatment decisions made by Physicians.
About Leptomeningeal Metastases (LM)
LM is a rare complication of cancer in which the primary cancer spreads to the cerebrospinal fluid (CSF) and leptomeninges surrounding the brain and spinal cord. All malignancies originating from solid tumors, primary brain tumors, or hematological malignancies have this LM complication potential with breast cancer as the most common cancer linked to LM, with 3-5% of breast cancer patients developing LM. Additionally, lung cancer, GI cancers and melanoma can also spread to the CSF and result in LM. LM occurs in approximately 5% of people with cancer and is usually terminal with 1-year and 2-year survival of just 7% and 3%, respectively. The incidence of LM is on the rise, partly because cancer patients are living longer and partly because many standard chemotherapies cannot reach sufficient concentrations in the spinal fluid to kill the tumor cells, yet there are no FDA-approved therapies specifically for LM patients, who often succumb to this complication within weeks to several months, if untreated.
About Rhenium (186Re) obisbemeda
Rhenium (186Re) obisbemeda is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. Rhenium (186Re) obisbemeda has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. Rhenium (186Re) obisbemeda is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT).
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This presentation contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “potential,” “anticipating,” “planning” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of rhenium (186Re) obisbemeda including the ability of rhenium (186Re) obisbemeda to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM, ReSPECT-LM and ReSPECT-PBC and increase of ten o, clinical trials; possible negative effects of rhenium (186Re) obisbemeda; the continued evaluation of rhenium (186Re) obisbemeda including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms, and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2023, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Charles Y. Huang, MBA
Director of Capital Markets and Investor Relations
Office: (202)-209-5751 | Direct (301)-728-7222
mailto://chuang@plustherapeutics.com
Paulness
7月前
NEWS -- Plus Therapeutics Receives $3 Million Award Recommendation from the United States Department of Defense
Plus now has $23 million in active awards support for the Company’s targeted radiotherapeutic pipeline
Funding for pediatric brain cancer treatment is expected to begin in Q3 2024, pending contract finalization
AUSTIN, Texas, April 22, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announced it has been selected for funding by the Department of Defense (DoD) office of the Congressionally Directed Medical Research Programs (CDMRP). The award is expected to commence in Q3 2024 and will support the planned expansion of the Company’s clinical trial for pediatric brain cancer.
“This recent award further extends our current cash runway in the second half of 2025, while supporting the 2024 expansion of our clinical development activities,” said Marc H. Hedrick, M.D., President & CEO of Plus Therapeutics. “In 2023, the Company applied for approximately $7 million in grant funding, and we plan to file for more than $10 million in funding in 2024.”
About the DoD Grant Program
The DoD Peer Reviewed Cancer Research Program (PRCRP) Advancing Cancer Care through Clinical Trials Award will be utilized to fund a Phase 1 dose escalation trial to address the FY23 PRCRP Topic Area of Pediatric Brain Tumors. This study will investigate a novel therapeutic, Rhenium (186Re) Obisbemeda (186RNL), delivered by Convection Enhanced Delivery (CED), for the treatment of supratentorial recurrent, refractory, or progressive pediatric high-grade glioma (HGG) and ependymoma. It is expected to begin enrollment in the second half of 2024.
About Rhenium (186Re) obisbemeda
Rhenium (186Re) obisbemeda is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. Rhenium (186Re) obisbemeda has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. Rhenium (186Re) obisbemeda is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT).
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This presentation contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “potential,” “anticipating,” “planning” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of rhenium (186Re) obisbemeda including the ability of rhenium (186Re) obisbemeda to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM, ReSPECT-LM and ReSPECT-PBC and increase of ten o, clinical trials; possible negative effects of rhenium (186Re) obisbemeda; the continued evaluation of rhenium (186Re) obisbemeda including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms, and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2023, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Charles Huang
Director, Capital Markets and Investor Relations
(202) 209 5751
mailto://chuang@plustherapeutics.com
Paulness
8月前
NEWS -- Neuro-Oncologist Andrew Brenner, M.D., Ph.D. and Barbara Blouw, Ph.D. Join Plus’ Management Team
The addition of both Dr. Brenner and Dr. Blouw substantially expands Plus internal expertise in key areasDr. Brenner will maintain his academic commitments but will greatly contribute to Plus’ scientific and clinical efforts to develop targeted radiotherapeutics for central nervous system (CNS) cancersDr. Blouw is an expert in CNS tumor biology and in the diagnosis of neoplasms of the cerebrospinal fluidAUSTIN, Texas, April 09, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announced that Andrew Brenner, M.D., Ph.D. (Professor-Research, Departments of Medicine, Neurology, and Neurosurgery & S & B Kolitz/CTRC-Zachry Endowed Chair Neuro-Oncology Research, Mays Cancer Center at UT Health San Antonio) has formally joined the Company in a part-time capacity. Dr. Brenner will provide substantial input on the Company’s central nervous system cancer development programs while continuing to maintain his academic practice and laboratory. In addition, Barbara Blouw, Ph.D. joins the Company as Vice President, Clinical Affairs.
“I am excited to be working more closely with the Plus team to accelerate the development of its radiopharmaceutical pipeline,” said Andrew Brenner, M.D., Ph.D. “Rhenium (186Re) obisbemeda has the potential to transform the treatment of CNS cancers, and I am pleased to be able to increase my commitment to Plus with the goal of accelerating the late-stage clinical development of the company’s existing trials in recurrent glioblastoma (GBM), leptomeningeal disease and pediatric brain cancer.”
Dr. Brenner is a board-certified internist, medical oncologist, and tumor biologist with a focus in drug development for the management of primary brain tumors and breast neoplasms. Dr. Brenner’s academic work focuses on both clinical cancer management and the development of novel therapies to treat breast and central nervous system tumors. Dr. Brenner has received numerous grants and investigational new drug approvals based on his translational research. Additionally, he has led multiple multicenter trials for the treatment of CNS neoplasms and served on Steering Committees for Phase III trials in GBM. He is a graduate of Texas A&M University and earned his doctorate in biological science and tumor biology at the University of Texas M.D. Anderson Cancer Center – Science Park. Dr. Brenner received his medical degree from the Texas Tech University Health Science Center and completed a residency at Texas A&M Health Science Center in Temple, Tx. He completed his fellowship in medical oncology at UT Health San Antonio.
Dr. Barbara Blouw has a Ph.D. from Utrecht University in the Netherlands and completed her postdoctoral research at the Sanford Burnham Prebys, Medical Discovery Institute, and the University of California, San Diego Division of Biological Sciences in basic cancer biopsy. Professionally, she has worked for Navigate Biopharma (a Novartis Company), Halozyme and Biocept. Dr. Blouw has a broad background in oncology research, clinical trial design, regulatory submissions, biostatistics, and clinical operations. She also has expertise in CNS biomarker development using in vitro and in vivo preclinical models and assay development and validations for clinical trial testing per the College of American Pathologists Laboratory Accreditation Program and Clinical Laboratory Improvement Amendments.
“As we prepare for the future, Plus is substantially strengthening its management in key areas such as cancer biology, neuro-oncologic clinical development, and central nervous system biomarker development,” said Marc H. Hedrick, M.D., M.B.A. “I have worked closely with both Dr. Brenner and Dr. Blouw for some time now, and they are important new additions for our future. Their positive impact will be felt immediately.”
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “potential,” “anticipating,” “planning” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of rhenium (186Re) obisbemeda including the ability of rhenium (186Re) obisbemeda to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM, ReSPECT-LM and ReSPECT-PBC and increase of ten o, clinical trials; possible negative effects of rhenium (186Re) obisbemeda; the continued evaluation of rhenium (186Re) obisbemeda including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms, and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2023, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
(212) 915-2577
mailto://cdavis@lifesciadvisors.com
Paulness
8月前
NEWS -- Plus Therapeutics to Present at the National Comprehensive Cancer Network Annual Conference
AUSTIN, Texas, March 27, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announced that it will present a poster at the National Comprehensive Cancer Network (NCCN) 2024 Annual Conference, which will be held April 5-7, 2024, in Orlando, Florida.
NCCN 2024 Annual Conference – Orlando World Center Marriott
Poster: Friday, April 5, 2024 at 7:30am-8:30 am and 11:55am – 1:10 pm ET in the Exhibition Hall
Title: Rhenium (186Re) Obisbemeda (186RNL) in Leptomeningeal Metastases Phase 1 Dose Escalation Trial: Update of Initial Safety and Feasibility
Presenter: Norman LaFrance, MD, ME, FACP, FACNP, FACNM (Chief Medical Officer of Plus Therapeutics)
A copy of the poster presentation will be made available under the Presentations tab of the Investors section of the Company’s website following the meeting at https://ir.plustherapeutics.com.
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “potential,” “anticipating,” “planning” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of rhenium (186Re) obisbemeda including the ability of rhenium (186Re) obisbemeda to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM, ReSPECT-LM and ReSPECT-PBC and increase of ten o, clinical trials; possible negative effects of rhenium (186Re) obisbemeda; the continued evaluation of rhenium (186Re) obisbemeda including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms, and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2023, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
(212) 215-2577
mailto://cdavis@lifesciadvisors.com
Paulness
8月前
NEWS -- Plus Therapeutics Announces Validation & Clinical Implementation of CSF-01 Leptomeningeal Cancer Cell Diagnostic
Plus’ CSF-01 cancer cell enumeration test is a sensitive and specific diagnostic test for the presence of adenocarcinoma and melanoma cancer cells in the leptomeninges
CSF-01 testing is used as an exploratory endpoint in the ReSPECT-LM trials
Controlled clinical trial data evaluating the utility of CSF-01 in clinical decision-making is anticipated to be released in Q2/Q3 2024
AUSTIN, Texas, March 25, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announced it has successfully completed key validation testing and implementation of its tumor cell enumeration assay, known as CSF-01, to be used initially as an exploratory endpoint in its ReSPECT-LM clinical trials.
“Plus’ CSF-01 tumor cell enumeration assay is a highly specific and sensitive diagnostic test that is promising for both establishing the diagnosis of leptomeningeal metastases (LM) and following the disease course over time,” said Dr. Priya Kumthekar, Associate Professor, Feinberg School of Medicine, Northwestern University. “Current diagnostic methods lack the sensitivity and specificity to reliably inform clinical decision making, and the field is excited about the use of CSF-01 in the ReSPECT-LM trials as an exploratory endpoint and hopefully soon, for use in all patients in which LM is in the differential diagnosis.”
Plus’ CSF-01 cancer cell enumeration test is an exploratory endpoint in the ReSPECT-LM Phase 1 trial that has shown promise in the trial’s early cohorts. In Phase 1/Part A of the ReSPECT-LM trial presented at the 2023 SNO/ASCO Meeting in San Francisco, Plus showed an average 53% reduction in CSF tumor cells 28 days after a single intrathecal administration of rhenium (186Re) obisbemeda in patients with LM.
“In mid-2023, the Company licensed CSF-01, as well as a broader CSF diagnostic testing portfolio due to high conviction that routine implementation will substantially improve diagnosis and clinical management of LM,” said Marc H. Hedrick, M.D., President & CEO of Plus Therapeutics. “Our initial objective was to make the test available for our ReSPECT-LM trial patients, which is now complete. Now, we are evaluating the FORSEE clinical trial data, which we anticipate reporting in the second or third quarter of 2024.”
On December 12, 2023, Plus announced its partnership with K2bio (Houston, Texas) to implement Plus’ CSF-01 diagnostic for LM cancers in the ReSPECT-LM trials. While validated for use in Plus’ clinical development programs, full Clinical Laboratory Improvement Amendments (CLIA) certification is not anticipated until 2025. The ReSPECT-LM trial, including support for CSF-01 testing, is currently receiving grant funding from the Cancer Prevention and Research Institute of Texas (CPRIT).
The FORSEE trial was performed by the original developer and licensor of CSF-01 and is a multi-center, prospective clinical trial enrolling patients with breast or non-small cell lung cancer (NSCLC) who have suspicious or confirmed LM. If the FORSEE data is positive, we intend to work toward increasing commercial reimbursement for the CLIA-certified test and explore partnerships to maximize diagnostic utilization for the broader CNS cancer space.
About Leptomeningeal Metastases (LM)
LM is a rare complication of cancer in which the primary cancer spreads to the cerebrospinal fluid (CSF) and leptomeninges surrounding the brain and spinal cord. All malignancies originating from solid tumors, primary brain tumors, or hematological malignancies have this LM complication potential with breast cancer as the most common cancer linked to LM, with 3-5% of breast cancer patients developing LM. Additionally, lung cancer, GI cancers, and melanoma can also spread to the CSF and result in LM. LM occurs in approximately 5% of people with cancer and is usually terminal, with a 1-year and 2-year survival of just 7% and 3%, respectively. The incidence of LM is on the rise, partly because cancer patients are living longer and partly because many standard chemotherapies cannot reach sufficient concentrations in the spinal fluid to kill the tumor cells. Yet, there are no FDA-approved therapies specifically for LM patients, who often succumb to this complication within weeks to several months if untreated.
About Rhenium (186Re) obisbemeda
Rhenium (186Re) obisbemeda is a novel injectable radiotherapy specifically formulated to deliver directly targeted high-dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. Rhenium (186Re) obisbemeda has the potential to reduce off-target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. Rhenium (186Re) obisbemeda is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT).
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “potential,” “anticipating,” “planning” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of rhenium (186Re) obisbemeda including the ability of rhenium (186Re) obisbemeda to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM, ReSPECT-LM and ReSPECT-PBC and increase of ten o, clinical trials; possible negative effects of rhenium (186Re) obisbemeda; the continued evaluation of rhenium (186Re) obisbemeda including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms, and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2023, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
(212) 215-2577
mailto://cdavis@lifesciadvisors.com
Paulness
9月前
NEWS -- Plus Therapeutics Completes Dosing in Cohort 5 of ReSPECT-LM Phase 1 Trial of Rhenium (186Re) Obisbemeda in Leptomeningeal Metastases
A total of 18 patients have been dosed in the trial to date
Company anticipates moving into Cohort 6 in Q2 2024 following standard safety review
AUSTIN, Texas, March 11, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announced it has completed dosing in Cohort 5 of the ReSPECT-LM Phase 1 dose escalation clinical trial of rhenium (186Re) obisbemeda for the treatment of leptomeningeal metastases (LM) from solid tumors.
Three patients were dosed as part of Cohort 5, bringing the total to 18 patients dosed in the ReSPECT-LM trial to date. There have been no dose limiting toxicities observed to date with administered radiation doses up to 66.14 millicuries in Cohort 5, a ten-fold increase over Cohort 1. The Company plans to initiate dosing in Cohort 6 in the second quarter of 2024, pending Data Safety Monitoring Board (DSMB) approval. In addition, five new clinical trial sites were added to this trial over the last year, bringing the total number of sites to seven. The Company anticipates that this will allow for continued maximal enrollment allowed under the protocol.
The FDA has granted Fast Track designation to rhenium (186Re) obisbemeda for LM and Orphan Drug Designation for the treatment of breast cancer with LM, and the ReSPECT-LM program continues to be funded in part by a 3-year $17.6M grant from the Cancer Prevention & Research Institute of Texas (CPRIT). Patients interested in learning more about the ReSPECT-LM trial can visit ClinicalTrials.gov (NCT05034497).
About Leptomeningeal Metastases (LM)
LM is a rare complication of cancer in which the primary cancer spreads to the cerebrospinal fluid (CSF) and leptomeninges surrounding the brain and spinal cord. All malignancies originating from solid tumors, primary brain tumors, or hematological malignancies have this LM complication potential with breast cancer as the most common cancer linked to LM, with 3-5% of breast cancer patients developing LM. Additionally, lung cancer, GI cancers and melanoma can also spread to the CSF and result in LM. LM occurs in approximately 5% of people with cancer and is usually terminal with 1-year and 2-year survival of just 7% and 3%, respectively. The incidence of LM is on the rise, partly because cancer patients are living longer and partly because many standard chemotherapies cannot reach sufficient concentrations in the spinal fluid to kill the tumor cells, yet there are no FDA-approved therapies specifically for LM patients, who often succumb to this complication within weeks to several months, if untreated.
About Rhenium (186Re) obisbemeda
Rhenium (186Re) obisbemeda is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. Rhenium (186Re) obisbemeda has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. Rhenium (186Re) obisbemeda is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT).
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “potential,” “anticipating,” “planning” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of rhenium (186Re) obisbemeda including the ability of rhenium (186Re) obisbemeda to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM, ReSPECT-LM and ReSPECT-PBC and increase of ten o, clinical trials; possible negative effects of rhenium (186Re) obisbemeda; the continued evaluation of rhenium (186Re) obisbemeda including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms, and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2023, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
(212) 215-2577
mailto://cdavis@lifesciadvisors.com
Paulness
9月前
NEWS -- Plus Therapeutics, Inc. (NASDAQ:PSTV) Q4 2023 Earnings Call Transcript
Plus Therapeutics, Inc. (NASDAQ:PSTV) Q4 2023 Earnings Call Transcript March 5, 2024
Plus Therapeutics, Inc. beats earnings expectations. Reported EPS is $-0.7, expectations were $-0.78. PSTV isn't one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).
Operator: Good afternoon, ladies and gentlemen. Welcome to the Plus Therapeutics Fourth Quarter and Full Year 2023 Results Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. Before we begin, we want to advise you that over the course of the call and question-and-answer session, forward-looking statements will be made regarding events, trends, business prospects and financial performance, which may affect Plus Therapeutics' future operating results and financial position. All such statements are subject to risks and uncertainties and including the risks and uncertainties described under the Risk Factors section included in Plus Therapeutics' annual report on Form 10-K and quarterly reports on Form 10-Q filed with the Securities and Exchange Commission from time to time.
Plus Therapeutics advises you to review these risk factors in considering such statements. Plus Therapeutics assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made. It is now my pleasure to turn the floor over to Dr. Marc Hedrick, Plus Therapeutics' President and Chief Executive Officer. Sir, you may begin.
Marc Hedrick: Thank you, Victor. Good afternoon, everyone, and thank you once again for taking the time to join us today as we provide an overview of recent business highlights and discuss our 2023 full year financial results. And right upfront, apologies for the hoarseness in my voice as I come back from the flu. Joining me for the call today are Mr. Andrew Sims, our Chief Financial Officer; and Dr. Norman LaFrance, our Chief Medical Officer. I'll begin the call this afternoon by reviewing our recent clinical and regulatory progress with a focus on the fourth quarter, and then turn the call over to Andrew to review our financials and Dr. LaFrance then will be joining us for Q&A. Let me begin with the updates on our two lead CNS cancer programs.
I think we're in an enviable position in the development of rhenium obisbemeda drug, in that with the recent progress we have made in LM. This effectively means we have two promising lead clinical programs for LM and recurrent GBM. Our ReSPECT-LM Phase 1/2 dose escalation trial of a single administration of rhenium obisbemeda for LM continues to show positive safety and efficacy signals and is making very good progress. In November 2023 at the Society for Neurooncology Meeting, or SNO, we presented results from the [technical difficulty], we showed that 13 patients with LM received a single intraventricular dose of rhenium obisbemeda between 6.6 escalating up to 44 millicuries through an indwelling Ommaya reservoir. No DLTs were observed and the maximum feasible dose was not reached.
The majority of adverse events were mild, 64% Grade 1 or moderate 27% Grade 2. And overall critical organ radiation doses were low. Rhenium obisbemeda circulated throughout the CSF space by one hour following administration and persisted in the CSF for up to seven days, again, with a single administration. CSF [technical difficulty] decreased by up to 91% following rhenium obisbemeda treatment, and the mean reduction was 53%. Seven of 13 treated patients remained alive at the time of reporting, with a median overall survival of 10 months for patients in the first three cohorts. That's cohorts one, two, three. Enrollment is on track to finish the Phase 1 single administration dose escalation trial by year-end 2024 and also along the way to determine a recommended Phase 2 dose for a single administration Phase 2/3 trial.
This assumes complete enrollment through cohort 7 and currently, we anticipate that cohort 7 is likely the max dose. Cohort 4 just completed was the fastest enrollment of all the cohorts to date and cohort 5 is now enrolling. I can tell you that for both the neuro-oncology community at sites, enthusiasm remains very high for this trial, and we have recently onboarded five new clinical trial sites. Later this year, our plan is to meet with the FDA and discuss the potential Phase 2/3 pivotal trial design, assuming the dataset remains positive and continue tolerated development approach focusing on metastatic breast cancer for which we have orphan designation. This would be for a single administration of rhenium obisbemeda. The trial size endpoints and other key trial elements will be discussed later on in the year, but we anticipate substantial financial support for this trial through our award.
In terms of LM data, we anticipate presenting interim safety and feasibility data from the ReSPECT-LM trial at the SNO/ASCO CNS Cancer Conference in August of 2024 and likely updating that for the full Phase 1 at the SNO Annual Meeting in November 2024. We are also currently working to expand the LM trial to accommodate multiple doses to maximize disease impact in the long term. As an aside, patients are requesting additional treatments of rhenium obisbemeda following their first administration in our current trial, so we are increasingly treating more patients with additional doses under compassionate use protocol, which anecdotally seems to be going well from both a safety perspective and the clinical impact, both of which are being closely followed.
We have developed a proposed approach for a multiple dose expansion and anticipate meeting with the FDA in 2024 with the goal of enrollment beginning for dosing expansion in early 2025, if not before. Now let's switch gears a bit, but still within the LM discussion. Please recall that we acquired rights to a highly specific sensitive cerebrospinal fluid tumor cell testing technology in September of 2023. We remain exceptionally encouraged by this test. But as you may recall, the prior company had very significant financial and operating issues. Our rationale for acquiring this was that because it could, A, double the market size for our LM therapeutic because of its significant diagnostic sensitivity improvement over standard-of-care but also it allows for longitudinal disease assessment that is otherwise very difficult or impossible to do with the current standard-of-care in testing.
The update on this test is that we have successfully implemented the test back into our ReSPECT-LM trial, losing only a few patients in cohort 4 as of February 2024. The diagnostic work is being conducted in conjunction with our partner, K2bio in Houston. The assay uses proprietary technology and a broad panel of 18 monoclonal antibodies largely geared towards various adenocarcinomas and melanoma. Working with K2, we can perform the test in a cost-effective manner for our trials and leverage existing grant funding for support. We are in the process of assessing whether broadening the test commercially beyond our trials and our current partnership with K2 is indeed viable. But overall, we continue to think this potential exciting new upside opportunity is great for the company.
Now finally, the ReSPECT-LM Phase 1 program continues to be funded in part through CPRIT, the state of Texas through a three-year $17.6 million product development research award. That continues to go very well. And in September, we received a planned $1.9 million payment followed by a $3.3 million payment this past December as part of the grant contract. To date, we have received approximately $7 million from CPRIT, and we anticipate receiving an additional $6.9 million throughout 2024. And I think Andrew will provide more detail on the CPRIT grant revenue in a moment. Now an update on our ReSPECT-GBM trial of a single dose of rhenium obisbemeda given via convection-enhanced delivery to patients with recurrent glioblastoma or GBM. ReSPECT-GBM continues to enroll patients, and we are actively adding new clinical trial sites.
Until recently, we have been limited in terms of trial sites based on the NCI NIH grant funding award, which has substantially supported this trial through the principal investigator, Dr. Andrew Brenner and the University of Texas. Going forward, in 2024, we will expand trial sites, more efficiently interface with sites and provide broader and more direct corporate support for the trial. We are incredibly grateful for the five-year support from the NCI University of Texas and the trial PI, up to this point, as we take the ball and move the trial from Phase 2 to a pivotal trial. We anticipate adding a total of five to eight new sites this year, which is currently ongoing, and we think that's going to provide a strong starting basis for a pivotal trial commencing in 2025.
The impact of those sites of enrollment will be felt in the latter part of 2024, and we hope to complete Phase 2 enrollment in late 2024 or early 2025. Last November, we presented initial positive safety and feasibility data from the Phase 2 ReSPECT-GBM trial at the SNO meeting last November. As a reminder, the primary endpoint of that Phase 2 is to assess overall survival following a single dose of rhenium obisbemeda in recurrent GBM and compare that to standard-of-care. In summary, that data showed median overall survival in the 15 patients from the Phase 2 study treated at that time was 13 months median overall survival, 13 months versus approximately eight months for the standard of care, and nine of the 15 patients remained alive at the time of the analysis.
Median progression-free survival was 11 months compared to bevacizumab, which is 3.4 months. Rhenium obisbemeda continues to demonstrate a very favorable safety profile despite delivering up to 20x the dose of radiation that is typically delivered by external beam radiation therapy for GBM, and that's typically around 35 gray and we've gone up to 740 gray and the mean dose we're giving now is about 300 to 350 gray. In 13 of 15 patients or 86% of patients have thus far met the empirically derived rhenium obisbemeda dosing target threshold that we've established in Phase 1 and in preclinical studies of greater than 100 gray average absorbed dose to the tumor in greater than 70% tumor coverage. The Phase 2 trial performance in terms of median overall survival will be controlled in the Phase 2 using real-world data generated in conjunction with our partner metadata who has a sizable database in GBM in a history of using that successfully in GBM trials with the FDA.
In the Phase 1, with metadata, we conducted two real-world data trials in our GBM and one versus bevacizumab monotherapy and another versus other convection-enhanced delivery trials that were propensity matched to our Phase 1 data. In those two trials in terms of median overall survival, that was aligned with the recent meta-analysis showing current standard-of-care in recurrent GBM in terms of median overall survival is approximately eight months. And so currently, we view that as an effective clinical hurdle rate, if you will, in a Phase 2 and in a pivotal. So comparing our Phase 2 data as it stands to - as of November of last year versus real-world data, that's the last time we reported data, a median overall survival, as a reminder, was 13 months, which is 63% better than current standard-of-care which is bevacizumab monotherapy, for example, that has - carries an overall survival of approximately eight months.
Also, I'd like to highlight another presentation of our imaging data that was also presented at the same meeting in November by the trial PI. Imaging is an important secondary endpoint in the trial, supporting the overall survival signal. It has until recently been difficult to assess because pseudo progression has been commonly noted in patients that are receiving such a high dose of radiation, namely 10x to 20x over EBRT. It was a very technical presentation and can be found on our website, but the bottom line is that using advanced imaging techniques beyond standard MRI and T1 T2-weighted images, using things such as relative cerebral blood volume, treatment response assessment maps and fit books, we can increasingly, if not reliably delineate pseudoprogression from progression as well as better understand patterns of recurrence, and we think this is going to help ensure that we are able to more rapidly develop and improve upon this novel new therapy for GBM, but also adapted for primary GBM and other brain cancers in children and adults.
And related to that point above, I thought it might be useful for me to take a couple of minutes and do a little bit of a forward-looking reframe of this GBM development program that we've been working on and look at it in sort of a unique way based on what we've learned over the last over three years of development. In my view, what we've developed is not - it's not ideal to think about this as sort of a pure-play GBM drug therapeutic per se. But rather, I think it's more accurate to think about this as a novel targeted radiotherapeutic delivery ecosystem that can overcome not just the limitations of external beam radiation therapy, which is the mainstay of GBM therapy. In other words, we've increased by 10x to 20x the amount of absorbed radiation dose over EBRT.
But when you couple that with the state-of-the-art imaging, the custom treatment planning with specific software that's now available, the neuronavigational technology and convection-enhanced delivery catheters that are optimized, we can also overcome the limitations of blood brain barrier that makes drugging GBM a very challenging matter and also overcome the limitations of the aggressive local invasiveness that is well known with GBM, which makes complete surgical resection almost impossible. So given the safety margins that we have seen thus far, with only a single administration of the radiotherapeutic drug and using the convection-delivery modality, we see tremendous opportunity and potential in both improving upon the standard-of-care in radiation delivery for GBM, which is EBRT in general but also improve upon current standard approaches for recurrent GBM such as surgery and chemotherapeutics and then expanding into other CNS tumor types of the brain parenchyma.
And I'm happy to discuss this more in the Q&A session. Now in terms of data, we anticipate an update at SNO in November 2024. We also intend to meet with the FDA in 2024, both on the GBM pivotal trial design and to obtain FDA IND approval to begin enrollment of the ReSPECT pediatric brain cancer trial for children with high-grade glioma and ependymoma. To meet our clinical goal of being in pivotal trials in 2025 with rhenium obisbemeda drug, we are focused in 2024 to expand our GMP manufacturing relationships, such that we have two fully validated manufacturers that can support primary drug supply, backup drug supply, scale-up activities and all foreseeable commercial demand forecast. So relatedly, we are working to build in redundancy in all supply chain intermediaries, including radioisotope target and radiation services.
We think rhenium is an exciting new clinically relevant radioisotope and interest in that is very high. We are currently on track to meet both of these important drug production supply objectives. In terms of building out the pipeline, we are focusing on two discrete areas. Our new radiotherapeutic, which is rhenium nanoliposome biodegradable alginate microsphere long term, but we call it RNL BAM and building on our organizational expertise and success in obtaining nondilutive grant funding. First, as it relates to RNL BAM, as a reminder, this is a next-generation radioembolic device as it's now designated by the FDA as of last year, which is designed to treat a variety of solid organ tumors. As the FDA path is now resolved, we are analyzing key device design attributes that we think will ensure this is an attractive product for both liver cancer and other cancers, and we'll provide more updates as that develops over the year.
Second, as to the issue of grants. We currently have over $20 million in active awarded funding for our two lead programs in LM and GBM. In 2023, we filed for approximately $7 million in grant funding and plan to increase that to at least $10 million in 2024. As per our practice, we report on specific grant funding only when awarded. Now with that update, I'll turn the call over to our CFO, Andrew Sims, who will review the financials. Andrew?
Andrew Sims: Thank you, Marc, and good afternoon, everyone. Please refer to our press release issued earlier today for a summary of our financial results for the fourth quarter and year ended December 31, 2023. As of December 31, 2023, cash and cash equivalents were $8.6 million compared to $18.1 million as of December 31, 2022. We are projected to receive an additional $6.9 million in grant funding from CPRIT in 2024, with $3.3 million in the first half of 2024, and a balance of $3.6 million by the end of the year. In addition, as Marc mentioned, the company continues to benefit from grant awards of $3 million from the NIH to support the GBM trial through Phase 2. Based on the cash on hand and committed grant funding, our current balance sheet provides runway into the second half of 2025.
The company recognized $4.9 million of grant revenue during the year ended December 31, 2023, compared to $0.2 million in 2022, reflecting the progress made on the LM indication in 2023. We expect grant revenue will continue to increase during 2024 and the remaining term of the CPRIT grant through August 2025 as we plan to expand the LM clinical trial to add clinical sites and enroll additional patients. Total operating expenses for the year ended December 31, 2023 of $18.2 million compared to $19.7 million in the same period 2022. The decrease due to lower professional and legal expenses. Other income increased from $147,000 in 2022 to $400,000 in 2023 and fully offset interest expense. As a result of these changes, the net loss decreased by $6.9 million from $20.3 million in the year ended December 31, 2022, to $13.3 million in the year ended December 31, 2023.
And now I'll turn it back to you, Marc.
Marc Hedrick: Great. Thank you, Andrew. Before we move on to Q&A, I'll take a moment to provide guidance on selected key milestones anticipated over the next 12 months. First, we had safety and efficacy data from the Phase 1 ReSPECT-LM trial with the SNO/ASCO CNS meeting in August of 2024 and likely further update at the full-on SNO meeting in October 2024. We anticipate completing the Phase 1 trial in LM by the end of 2024, and we're on track [technical difficulty] conjunction develop a Phase 2/3 pivotal trial design for breast cancer patients with LM in conjunction with the FDA. We will also be working with the FDA in 2024 to develop a multiple dosing approach to potentially further extend tumor impact of the rhenium obisbemeda and leptomeningeal patients.
In our GBM program, we intend to expand trial sites, as mentioned, and complete enrollment in the Phase 2 trial by late 2024 or early 2025 and in parallel finalized pivotal trial design planning with the FDA that's partially done at this point. Pending IND clearance from the FDA, we intend to initiate the Phase 1 pediatric brain cancer trial for pediatric brain cancer patients. And we also plan to bolster our rhenium obisbemeda supply chain for commercial readiness in 2024 as well as complete device development optimization milestones for our next-generation radioembolic device, RNL BAM. Now with those key milestones, I'll turn the call back over to Victor to introduce any questions we might have. Victor?
To continue reading the Q&A session, please click here.
Paulness
9月前
NEWS -- Plus Therapeutics to Announce Fourth Quarter and Full Year 2023 Financial Results and Host Conference Call on March 5, 2024
AUSTIN, Texas, Feb. 27, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced that the Company will report fourth quarter and full year 2023 financial results on Tuesday, March 5, 2024, after market close. Plus Therapeutics’ management team will then host a conference call and webcast at 5:00 p.m. ET to discuss the financial results and provide a corporate update.
Conference Call & Webcast
Tuesday, March 5, 2024 @ 5:00 PM ET
Dial-in Link: https://register.vevent.com/register/BIa3e26b40a05b4e7185cb3d97450dd3c4
Webcast: https://edge.media-server.com/mmc/p/p7t4p29q
Participants may also pre-register any time before the call through the dial-in link. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial in 15 minutes prior to the start time.
Following the live call, a replay will be available on the Company’s website under the ‘For Investors’ section. The webcast will be available on the Company’s website for 90 days following the live call.
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a robust supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of 186Re including the ability of 186Re to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM and ReSPECT-LM clinical trials; possible negative effects of 186Re; the continued evaluation of 186Re including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
(212) 215-2577
mailto://cdavis@lifesciadvisors.com
Paulness
12月前
NEWS -- Plus Updates Financial and Cash Guidance for 2024
Plus Receives $3.3M in grant revenue in Q4 2023
Forecasts additional $6.9M of grant revenue for 2024
Enters into debt restructuring deal with Pershing Capital to reduce 2024 cash burn by $3.7M
AUSTIN, Texas, Dec. 18, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announced financial updates and guidance for 2024.
Plus is currently in the second year of a Cancer Prevention and Research Institute of Texas (CPRIT) award totaling $17.8 million. The grant funds are advances on future spend and received based on hitting certain milestones. The $3.3 million payment is the first advance for the second year of the award. The Company forecasts an additional $6.9 million in grant revenue during the 2024 calendar year.
Furthermore, the Company currently has a debt facility with Oxford Finance LLC. The remaining balance of the facility is $0.7 million as of YE 2023 with a $3.3 million deferred interest payment due in June 2024. The new facility carries a lower interest rate and principal payment flexibility allowing for principal payments to be deferred into 2025 and beyond and is expected to close in January 2024.
“This combination of forecasted non-dilutive grant revenue and debt restructuring significantly strengthens our balance sheet and reduces our burn,” said Andrew Sims, Chief Financial Officer of Plus Therapeutics. “Following closure of the debt restructure, the Company should have capital sufficient to extend the runway to the second half of 2025.”
To date, the Company has received $7 million from CPRIT and, in 2024, anticipates receiving an additional $6.9 million, $3.3 million in Q2 and $3.6 million in Q4, as part of the planned cadence of award payments. The Company reported $11.0 million in cash as of September 30, 2023. The Company believes that the award payment together with its cash on hand provide sufficient runway to fund operations to the second half of 2025.
Plus’ grant from CPRIT provides for funding over the three-year grant period which began on August 31, 2022, and covers the majority of the development costs of the Company’s lead investigational targeted radiotherapeutic, rhenium (186Re) obisbemeda, for the treatment of patients with leptomeningeal metastases (LM).
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a robust supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
About the Cancer Prevention & Research Institute of Texas (CPRIT)
CPRIT was created by the Texas Legislature and approved by a statewide vote in 2007 to lead the Lone Star State’s fight against cancer. In 2019, Texas voters again voted overwhelmingly to continue CPRIT with an additional $3 billion for a total $6 billion investment in cancer research and prevention.
To date, CPRIT has awarded over $3 billion in grants to Texas research institutions and organizations through its academic research, prevention and product development research programs. CPRIT has recruited 281 distinguished researchers, supported the establishment, expansion or relocation of 52 companies to Texas and generated over $7.66 billion in additional public and private investment. CPRIT funding has advanced scientific and clinical knowledge and provided 8.2 million life-saving cancer prevention and early detection services reaching Texans from all 254 counties. Learn more at cprit.state.tx.us.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,”, “forecast”, “believes”, “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of 186Re including the ability of 186Re to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM and ReSPECT-LM clinical trials; the anticipated completion of the ReSPECT-GBM Phase 2 enrollment; the continuation of the ReSPECT-GBM phase 1 trial to maximum tolerated dose and the next phase of the program; the continued evaluation of rhenium (186Re) obisbemeda including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
(212) 215-2577
mailto://cdavis@lifesciadvisors.com
Paulness
12月前
NEWS -- Plus Therapeutics Partners With K2bio for Development of Novel Tests for Cerebrospinal Fluid (CSF) Tumor Cell and Molecular Biomarker Analyses
Collaboration to explore novel CSF cancer testing modalities and initial testing panel to be available in Q1 2024 for ReSPECT-LM patients
AUSTIN, Texas, Dec. 12, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announced that it has partnered with K2bio (Houston, Texas) to implement novel analysis for cerebrospinal fluid (CSF) tumor and molecular biomarkers for CNS cancers. Initial clinical specimen processing and testing will begin in Q1 2024 in the Company’s ongoing Phase 1 ReSPECT-LM trial of rhenium (186Re) obisbemeda in patients with leptomeningeal metastases (LM). This trial is currently receiving grant funding through The Cancer Prevention and Research Institute of Texas (CPRIT). The Company expects testing costs to be partially covered under this grant.
“The initial diagnosis, therapeutic selection and monitoring of patients with CNS cancers such as leptomeningeal metastases are significant problems in everyday clinical practice,” said Marc H. Hedrick, M.D., President & Chief Executive Officer of Plus Therapeutics. “To turn these very lethal CNS cancers into treatable diseases, we must ideally address both the diagnostic as well as the therapeutic needs of caregivers and patients. This partnership with K2bio is the next part of our overall strategy to address both needs in parallel.”
K2bio is a hybrid contract research organization (CRO) enabling life science companies to develop the next generation of innovative therapies. K2bio is based in Houston and is part of the Texas Medical Center life sciences ecosystem specializing in all aspects of translational cancer diagnostic and therapeutic research and development.
“K2bio is a leader in enabling rapid diagnostic and therapeutic progress for innovative companies such as Plus,” said Colby Suire, PhD, acting President and CEO of K2bio. “We have all the necessary capabilities and expertise to accelerate and support Plus’ mission to be a leader in the development of targeted radiotherapeutics and related diagnostics for CNS cancers.”
Plus’ tumor cell and molecular biomarker analysis is an exploratory endpoint in the ReSPECT-LM Phase 1 trial that has shown promise in early cohorts. In Phase 1/part A of the ReSPECT-LM trial presented at the 2023 SNO/ASCO Meeting in San Francisco, Plus data showed an average 53% reduction in CSF tumor cells 28 days after a single intrathecal administration of rhenium (186Re) obisbemeda in patients with LM.
The FDA has granted Fast Track designation to rhenium (186Re) obisbemeda for the treatment of LM, and the ReSPECT-LM Phase 1 program continues to be funded in part by a 3-year $17.6 million grant from the Cancer Prevention & Research Institute of Texas (CPRIT). Patients interested in learning more about the ReSPECT-LM trial can visit ClinicalTrials.gov (NCT05034497).
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a robust supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of 186Re including the ability of 186Re to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM and ReSPECT-LM clinical trials; the anticipated completion of the ReSPECT-GBM Phase 2 enrollment; the continuation of the ReSPECT-GBM phase 1 trial to maximum tolerated dose and the next phase of the program; the continued evaluation of rhenium (186Re) obisbemeda including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
(212) 215-2577
mailto://cdavis@lifesciadvisors.com
Paulness
1年前
NEWS -- Plus Therapeutics to Present at the 5th Targeted Radiopharmaceuticals Summit Europe
AUSTIN, Texas, Nov. 29, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced that Marc H. Hedrick, M.D., President and Chief Executive Officer, will deliver a presentation at the 5th Targeted Radiopharmaceuticals Summit Europe, being held December 5-7, 2023 in Berlin, Germany.
5th Annual Radiopharmaceuticals Summit Europe
Presentation Title: Re-186 Radiolabelled NanoLiposomes for Rare Brain and Spinal Cord Tumors
Date/Time: Wednesday, December 6, 2023 at 1:00 – 1:30pm CET
Session: Taking a Deep Dive into Novel Targets & Their Basics to Understand How They Affect TRP Development
Location: Berlin Marriott Hotel
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a robust supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of 186Re including the ability of 186Re to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM and ReSPECT-LM clinical trials; possible negative effects of 186Re; the continued evaluation of 186Re including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends, or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
(212) 915-2577
mailto://cdavis@lifesciadvisors.com
Paulness
1年前
NEWS -- Plus Therapeutics Reports New Interim ReSPECT-GBM Phase 2 Trial Data at the Society for NeuroOncology Annual Meeting and will Host Key Opinion Leader Webinar
Median overall survival (mOS) in 15 patients with recurrent glioblastoma (rGBM) from the Phase 2 study is 13 months, which is 63% better than current standard of care (bevacizumab monotherapy) of 8 months; 9 of the 15 patients remain aliveMedian progression free survival (mPFS) is 11 months, compared to SOC at 4 monthsRhenium (186Re) Obisbemeda continues to demonstrate a favorable safety profile, despite delivering up to 20x the dose of radiation (up to 740 Gy) typically delivered by external beam radiation therapy (EBRT) for rGBM patients (up to 35 Gy)Imaging data presented by Andrew Brenner, MD, PhD is consistent with the efficacy signal of Rhenium (186Re) Obisbemeda in rGBMCompany to Host Virtual KOL Webinar to Discuss Data Today at 10:00 am ETAUSTIN, Texas, Nov. 20, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced positive data from the ongoing ReSPECT-GBM Phase 2 trial evaluating the Company’s lead radiotherapeutic, rhenium (186Re) obisbemeda, for the treatment of recurrent glioblastoma (rGBM) at the Society for NeuroOncology (SNO) 28th Annual Meeting held November 15-19, 2023 in Vancouver, Canada. The Company is hosting a virtual key opinion leader (KOL) webinar to discuss the data today at 10:00 am ET. To register for the event, please click here.
“GBM needs better treatment options, and we are highly encouraged by the initial data from the NIH-supported ReSPECT-GBM Phase 2 trial of rhenium (186Re) obisbemeda in rGBM,” said Marc H. Hedrick, M.D., M.B.A., President and Chief Executive Officer of Plus Therapeutics. “We believe the data presented at SNO suggests that rhenium (186Re) obisbemeda confers a survival benefit over published standard of care data and our own real world data assessments of propensity matched controls. Our 2024 focus will be onboarding additional clinical sites, completing Phase 2 enrollment, continuing the Phase 1 trial to maximum tolerated dose, and planning next steps for the program.”
“The interim ReSPECT-GBM Phase 2 data coupled with the novel imaging analyses reported at SNO further strengthens the compelling therapeutic rationale for the use of rhenium (186Re) obisbemeda on malignant gliomas,” said Andrew J. Brenner, M.D., Ph.D., Professor of Medicine, Neurology, and Neurosurgery at The University of Texas Health Science Center at San Antonio and principal investigator of the ReSPECT-GBM clinical trial. “The Phase 2 clinical outcomes thus far show effects consistent with the group of patients in the Phase 1 dose escalation trial that received both a therapeutic dose of radiation of greater than 100 Gy and tumor coverage of greater than 70%."
Key Highlights from the ReSPECT-GBM Phase 2 Trial
ReSPECT-GBM is an ongoing, first-in-human, open-label, Phase 1/2 study investigating dose escalation and other delivery parameters (i.e., number of catheters (1-5), infusion rates, drug volumes, and drug concentrations) to determine the maximum tolerated dose (MTD), maximum feasible dose (MFD), safety, and efficacy of rhenium (186Re) obisbemeda in recurrent adult glioma (IND 116117).
The primary objective of the Phase 2 study is to assess overall survival (OS) following rhenium (186Re) obisbemeda administration. As of November 14, 2023, 15 patients with rGBM have been treated with rhenium (186Re) obisbemeda at a dose of 22.3 mCi delivered directly to the tumor by Convection Enhanced Delivery (CED).
In 15 treated patients, mOS is 13 months (95% CI 5 months). Currently, 9 out of the 15 treated patients remain alive.Median PFS is 11 months (95% CI 6-11 months).The average percent of treated tumor across all 15 patients was 87.2% at 120 hours, with 13/15 patients receiving greater than or equal 70% tumor volume coverage by the drug and =100 Gy absorbed dose to the tumor.Advanced longitudinal imaging analysis supports the observed efficacy signal of rhenium (186Re) obisbemeda.Rhenium (186Re) obisbemeda continues to be generally safe and well tolerated, consistent with data accumulated in the Phase 1 trial.A copy of the presentations will be made available under the Presentations tab of the Investors section of the Company’s website following the meeting at https://ir.plustherapeutics.com.
KOL Webinar to Discuss SNO Data
Plus Therapeutics is hosting a virtual KOL event today, November 20, 2023 at 10:00 am ET to discuss the data presented at SNO. The event will feature neuro-oncology expert and principal investigator Andrew Brenner, M.D., Ph.D. (Professor-Research, Departments of Medicine, Neurology, and Neurosurgery, S & B Kolitz/CTRC-Zachry Endowed Chair Neuro-Oncology Research, Mays Cancer Center at UT Health San Antonio) and neurosurgeons Toral Patel, M.D. (UT Southwestern Medical Center, Peter O’Donnell Jr. Brain Institute) and John Floyd, M.D. (UT Health San Antonio, UT Health Medical Arts & Research Center).
To register for the event, please click here. A replay of the event will be available on Investor Relations section of the Plus Therapeutics website after the event.
About Rhenium (186Re) obisbemeda
Rhenium (186Re) obisbemeda is a novel injectable radiotherapy specifically formulated to deliver highly targeted high dose radiation in CNS tumors in a safe, effective and convenient manner to optimize patient outcomes. Rhenium (186Re) obisbemeda has the potential to reduce risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue and gamma energy for live imaging. Rhenium (186Re) obisbemeda is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT).
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a robust supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of 186Re including the ability of 186Re to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM and ReSPECT-LM clinical trials; the anticipated completion of the ReSPECT-GBM Phase 2 enrollment; the continuation of the ReSPECT-GBM phase 1 trial to maximum tolerated dose and the next phase of the program; the continued evaluation of rhenium (186Re) obisbemeda including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
(212) 215-2577
mailto://cdavis@lifesciadvisors.com
Paulness
1年前
NEWS -- Plus Therapeutics to Host Virtual KOL Event on New Phase 2 ReSPECT-GBM Data in Recurrent Glioblastoma Presented at the Society for NeuroOncology (SNO) Conference on Monday, November 20, 2023
AUSTIN, Texas, Nov. 15, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced it will host a virtual KOL event on Monday, November 20, 2023 at 10:00 AM ET to discuss new Phase 2 ReSPECT-GBM data in recurrent glioblastoma presented at the Society for NeuroOncology (SNO) Conference. To register, click here.
The event will feature presentations from neuro-oncology expert and principal investigator Andrew Brenner, M.D., Ph.D. (Professor-Research, Departments of Medicine, Neurology, and Neurosurgery & S & B Kolitz/CTRC-Zachry Endowed Chair Neuro-Oncology Research, Mays Cancer Center at UT Health San Antonio) and neurosurgeons Toral Patel, M.D. (UT Southwestern Medical Center, Peter O’Donnell Jr. Brain Institute) and John Floyd, M.D. (UT Health San Antonio, UT Health Medical Arts & Research Center), who will discuss the unmet need and current treatment landscape for patients with rGBM, the potential of rhenium (186Re) obisbemeda in rGBM, and key highlights from the new Phase 2 data presented at SNO.
A live question and answer session will follow the formal presentations.
About Andrew Brenner, M.D., Ph.D.
Andrew Brenner, M.D., Ph.D., Professor-Research, Departments of Medicine, Neurology, and Neurosurgery & S & B Kolitz/CTRC-Zachry Endowed Chair Neuro-Oncology Research, Mays Cancer Center Center at UT Health San Antonio, is a specialist in both breast cancer and malignancies of the brain and spinal cord. He not only focuses on clinical management, but also on the development of novel therapies to treat breast cancers and central nervous system tumors.
A graduate of Texas A&M University, he earned his bachelor’s degree in biochemistry and went on to earn his doctorate in biological science and tumor biology at The University of Texas M.D. Anderson Cancer Center – Science Park. His doctoral thesis focused on the role of the cyclin dependent kinase inhibitor p16INK4a in mammary tumorigenesis and immortilization. Dr. Brenner’s current interests have transitioned from cell cycle to the effect of hypoxia on chemokines and escape from antiangiogenics and the role of obesity in promoting breast tumorigenesis.
Dr. Brenner received his medical degree from the Texas Tech University Health Science Center and completed a residency in internal medicine at Scott and White Hospital in Lubbock. He completed his fellowship in hematology and medical oncology at the UT Health San Antonio.
About Toral Patel, M.D.
Toral Patel, M.D., is an Assistant Professor in UT Southwestern Medical Center’s nationally ranked Department of Neurological Surgery, where she specializes in brain tumor surgery.
Dr. Patel received her undergraduate degree in biomedical engineering from Johns Hopkins University and earned her medical degree at UT Southwestern Medical School. She completed an internship in general surgery at Yale-New Haven Hospital, followed by a residency in neurological surgery, serving as Chief Resident. She then received advanced training in neurosurgical oncology through a fellowship at Memorial Sloan Kettering Cancer Center before returning to UT Southwestern as a faculty member in 2014.
Dr. Patel’s research has garnered numerous awards, including the William F. Collins Resident Research Award, a Seed Grant from the American Medical Association, the UT Southwestern Medical Student Summer Research Award, the Louis E. Goodman Award, and the Johns Hopkins University Department of Biomedical Engineering Undergraduate Research Award. She currently holds a patent titled “Highly penetrative nanocarriers for treatment of CNS disease” for her research into how nanoparticles can be used to carry drugs directly to the site of brain tumors.
Dr. Patel is a member of the Society for Neuro-Oncology, the American Medical Association, the American College of Surgeons, the Congress of Neurological Surgeons, and the American Association of Neurological Surgeons.
She was included in D Magazine‘s Best Doctors list for 2018.
About John Floyd, M.D.
John Floyd, M.D., Professor of Neurosurgery and Otolaryngology, serves as the Chair of the Department of Neurosurgery and the Carl Raba Family Chair in Neuro-Oncology at the Long School of Medicine at UT Health San Antonio. He began his medical career in high school after obtaining early acceptance to the University of Alabama School of Medicine at the age of 18. Prior to matriculating, Dr. Floyd finished his undergraduate degree, graduating summa cum laude. He studied public health policy and clinical trial design at the University of Adelaide, South Australia on a rotary international scholarship.
Dr. Floyd’s surgical training began at the prestigious Vanderbilt University Medical Center in Nashville, Tennessee, where he completed an internship in general surgery. Subsequently, he finished his neurosurgical training from the department of neurological surgery at Vanderbilt University Medical Center. Dr. Floyd has also completed a fellowship in neurosurgical oncology and skull base surgery at the University of Texas M.D. Anderson Cancer Center.
About Rhenium (186Re) obisbemeda
Rhenium (186Re) obisbemeda is a novel injectable radiotherapy specifically formulated to deliver highly targeted high dose radiation in CNS tumors in a safe, effective and convenient manner to optimize patient outcomes. Rhenium (186Re) obisbemeda has the potential to reduce risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue and gamma energy for live imaging. Rhenium (186Re) obisbemeda is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT).
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a robust supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the Company’s proposed share repurchase program; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical development plan and trials; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash; restrictions under the Company’s debt facility; the inability to repurchase shares, or a decision not to repurchase shares; future changes in strategic direction; unexpected expenses; the outcome of the Company’s partnering/licensing efforts; risks associated with laws or regulatory requirements applicable to the Company, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
(212) 215-2577
mailto://cdavis@lifesciadvisors.com
Paulness
1年前
NEWS -- Plus Therapeutics Granted U.S. FDA Orphan Drug Designation to Rhenium (186Re) Obisbemeda for the Treatment of Breast Cancer with Leptomeningeal Metastases
AUSTIN, Texas, Nov. 03, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to rhenium (186Re) obisbemeda for the treatment of breast cancer with leptomeningeal metastases (LM).
ODD status is granted by the FDA to an investigational drug or biological product intended to prevent, diagnose or treat a rare diseases or condition affecting fewer than 200,000 people in the United States. Companies granted ODD are eligible for certain benefits, including assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees and 7 years of post-approval marketing exclusivity.
“Receiving Orphan Drug Designation from the FDA is important validation of our radiotherapeutic candidate for breast cancer patients with LM who currently have no FDA-approved treatment options,” said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. “LM is a rapidly progressing and fatal complication of several cancers, including breast cancer, and incidence continues to rise. ODD status, together with the previously granted Fast Track designation, underscores the significant and urgent need for new treatment options for LM. We believe rhenium (186Re) obisbemeda has the potential to address this unmet need, and we look forward to continued progress of our ReSPECT-LM program.”
Rhenium (186Re) obisbemeda is currently being evaluated in the ReSPECT-LM Phase 1/2a dose escalation clinical trial. Cohort 4 of the ReSPECT-LM trial recently completed enrollment, and the Company anticipates moving into Cohort 5 following standard safety review. Updates on the ReSPECT-LM trial will be presented at the Society for Neuro-Oncology Annual Meeting November 15-19, 2023. In addition to ODD, the FDA previously granted rhenium (186Re) obisbemeda Fast Track designation for the treatment of LM.
About Leptomeningeal Metastases (LM)
LM is a rare complication of cancer in which the primary cancer spreads to the cerebrospinal fluid (CSF) and leptomeninges surrounding the brain and spinal cord. All malignancies originating from solid tumors, primary brain tumors, or hematological malignancies have this LM complication potential with breast cancer as the most common cancer linked to LM, with 3-5% of breast cancer patients developing LM. Additionally, lung cancer, GI cancers and melanoma can also spread to the CSF and result in LM. LM occurs in approximately 5% of people with cancer and is usually terminal with 1-year and 2-year survival of just 7% and 3%, respectively. The incidence of LM is on the rise, partly because cancer patients are living longer and partly because many standard chemotherapies cannot reach sufficient concentrations in the spinal fluid to kill the tumor cells, yet there are no FDA-approved therapies specifically for LM patients, who often succumb to this complication within weeks to several months, if untreated.
About Rhenium (186Re) obisbemeda
Rhenium (186Re) obisbemeda is a novel injectable radiotherapy specifically formulated to deliver highly targeted high dose radiation in CNS tumors in a safe, effective and convenient manner to optimize patient outcomes. Rhenium (186Re) obisbemeda has the potential to reduce risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue and gamma energy for live imaging. Rhenium (186Re) obisbemeda is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT).
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a robust supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the Company’s proposed share repurchase program; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical development plan and trials; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash; restrictions under the Company’s debt facility; the inability to repurchase shares, or a decision not to repurchase shares; future changes in strategic direction; unexpected expenses; the outcome of the Company’s partnering/licensing efforts; risks associated with laws or regulatory requirements applicable to the Company, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
(212) 215-2577
mailto://cdavis@lifesciadvisors.com
Paulness
1年前
NEWS -- Plus Therapeutics, Inc. (NASDAQ:PSTV) Q3 2023 Earnings Call Transcript
Plus Therapeutics, Inc. (NASDAQ:PSTV) Q3 2023 Earnings Call Transcript October 31, 2023
Operator: Good afternoon, ladies and gentlemen. Welcome to the Plus Therapeutics Third Quarter 2023 Results Conference Call. Before we begin, we want to advise you that over the course of the call and question-and-answer session, forward-looking statements will be made regarding events, trends, business prospects and financial performance, which may affect Plus Therapeutics' future operating results and financial position. All such statements are subject to risks and uncertainties, including the risks and uncertainties described under the Risk Factors section included in Plus Therapeutics' annual report on Form 10-K and quarterly reports on Form 10-Q filed with the Securities and Exchange Commission from time to time. Plus Therapeutics advises you to review these risk factors and considering such statements Plus Therapeutics assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.
It is now my pleasure to turn the floor over to Dr. Marc Hedrick, Plus Therapeutics' President and Chief Executive Officer. Sir, you may begin.
A medical scientist holding up a test tube, illustrating biopharmaceutical research.
Marc Hedrick: Thank you, Tawanda. Good afternoon, everyone. Thank you once again for taking time to join us today as we provide an overview of recent business highlights and discuss our 2023 third quarter financial results. Joining me for the call today are Mr. Andrew Sims, our Chief Financial Officer; and Dr. Norman LaFrance, our Chief Medical Officer. I'll begin the call by reviewing our recent clinical and regulatory progress with a focus on the third quarter and then turn the call over to Andrew to review our financials. Dr. LaFrance will then be joining us for Q&A. I'll begin with updates on our two lead radiotherapeutic CNS cancer programs, starting with recurrent glioblastoma rGBM. Our ReSPECT-GBM trial of Rhenium-186 Obisbemeda in patients with GBM funded substantially by the [Technical Difficulty] it is to enroll as we work to add new sites in order to complete enrollment of the Phase II by the end of 2024.
In parallel to the active Phase II trial, the Phase I dose escalation trial continues to enroll. Assessing the effects of very high administered radiation doses in large volumes to bigger size tumors on radiation distribution, tumor coverage and safety. We presented an update on the ReSPECT-GBM trial at the Society for Neuro-Oncology ASCO meeting in August. To summarize the safety data, a single administration of Rhenium-186 Obisbemeda is generally well tolerated with no dose-limiting toxicities and minimal systemic radiation exposure across 34 GBM patients. In addition, no patients experienced treatment-related adverse events with the outcome of death and no patients withdrew due to AEs. Most AEs were mild or moderate in intensity and nonserious.
The maximum tolerated dose was not reached. With regard to efficacy, as we briefly discussed last quarter, we found that overall survival is highly correlated with absorbed dose and treated tumor volume. In the data set presented at SNO/ASCO, the median absorbed radiation dose to the tumor was 308 gray. When we look at the median overall survival in the Phase I trial through Cohort 6, for patients with absorbed doses less than 100 grey, median overall survival was 22 weeks or about five months. And in contrast for patients with absorbed doses greater than 100 gray, median overall survival was 70 weeks or almost 18 months. Applying the Cox proportional hazard statistical model, we have found that for each 100 gray increase in total absorbed dose, the risk of death decreased by 45.6% and for each 10% increase in the ratio of treated to total tumor volume, the risk of death decreased by 66.9%.
This data can be found in much greater detail on our website. In addition, we continue to assess data from the ongoing Phase II trial. New safety and efficacy data from the Phase II will be presented at SNO in November. Following the SNO meeting, we will be hosting a key opinion leader webinar of investigators to discuss the data in detail. This webinar will feature Neuro-Oncology expert, Dr. Andrew Brenner, who is a principal investigator on the trial and is presenting the data at SNO as well as others. We'll be sharing the details of this event soon and invite you to join us as we delve into the data with these experts more deeply. Now let me update you on our ReSPECT-LM Phase I/IIa dose escalation trial of Rhenium Obisbemeda for patients with leptomeningeal metastases or LM.
This is a trial that is substantially funded by the State of Texas through CPRIT. Following a successful FDA Type C meeting in Q3, we rapidly completed Cohort 4 in the LM trial. Cohort 4 is the first of four planned cohorts in Part B of the Phase I trial. Completing the dosing in Cohort 4 was the fastest enrollment of all the cohorts to-date and enthusiasm from sites to participate enroll patients remains high. Prior to our FDA meeting, we completed Part A of the Phase I trial, specifically cohorts one through three. This past August, we presented the results of these cohorts at the SNO/ASCO meeting and provided further explanation and context at the KOL roundtable event following the August meeting. In summary, for the first three cohorts, the data shows a favorable safety profile and no dose-limiting toxicities have been reached.
Pharmacokinetic analysis showed that the drug circulated rapidly throughout the CSF space and remained there for at least seven days following single administration. Using the CNSide tumor cell enumeration assay, we found that an average reduction of tumor cell counts at 28 days post-treatment of 53%. And finally, median overall survival was 10 months with five of 10 patients still alive. We also presented LM data at the CPRIT innovations in cancer [Technical Difficulty] in September. As mentioned, the ReSPECT-LM Phase I program continues to be funded in part by CPRIT through a three-year $17.6 million product development research funding award. In September, we received a planned $1.9 million advanced payment as part of the grant contract.
Andrew will discuss the forecasted grant revenue going forward for the next couple of years in a moment. Now I'll provide some further color on the CNSide assay used in our LM trial and the license agreement we negotiated for the assay in August. Taking a look at the big picture first. The diagnosis of LM and the monitoring of treatment response are notoriously difficult in LM even with our state-of-the-art imaging clinical evaluation and traditional cerebrospinal fluid evaluation. In contrast, the CNSide assay is highly specific and sensitive as a measure of CSF tumor cell enumeration that quantitates a number of tumor cells per mL of CSF. This technology represents a substantial improvement in assessing CSF tumor cells compared to the standard of care.
At Plus, although we are initially pretty skeptical of the value of the technology and use it as a potential secondary endpoint, our team has seen the value of the assay first-hand in our LM trial and to paraphrase one of our LM trial investigators, the CNSide assay is a "game changer" for LM disease diagnosis and monitoring. And therefore, it's obviously quite synergistic with our therapeutic approach. The company that developed the test Biocept, those has been in financial distress throughout 2023 and declared their insolvency earlier this month. I want to make it clear that the company's financial distress was not in any way based on the quality of the utility of the assay, but upon a variety of unrelated factors. However, prior to Biocept's announcement and because of this very concern, Plus successfully completed the transfer of all proprietary materials [Technical Difficulty] and equipment from Biocept to use the CNSide assay.
And now as per our plan, we're the test to no longer be commercially available to us, as it is not now, Plus can now begin CSF tumor cell enumeration testing limited to the ReSPECT-LM trial patients. Separately, we will consider whether to exercise the exclusivity option that we have which is exercisable through the end of 2024 under the current license. In the meantime, we'll monitor the insolvency proceedings closely. Now back to our LM trial. We plan to initiate dosing in Cohort 5 this quarter pending DSMB approval. In terms of next step for ReSPECT-LM, we will continue to focus on enrollment, site on-boarding, data assessment and planning for next steps, including Phase II. In terms of our pediatric trial, we continue to make steady progress in initiating our first in child pediatric brain cancer trial.
Travel initiation is behind our original schedule as the FDA has required substantially more supporting data from us, particularly from our ongoing trials. We had a positive follow-up meeting in Q3, and all FDA requests are both reasonable and satisfactorily addressable within the next quarter. Thereafter, pending IND clearance from the FDA anticipated to be in early 2024, we plan to initiate the Phase I ReSPECT pediatric brain cancer trial for pediatric patients with the ependymoma and high-grade glioma at Lurie Children's Hospital in Chicago. Our other novel radiotherapeutic Rhenium-188 nanoliposome biodegradable alginate microsphere or BAM for short continues to make regulatory development progress. As a reminder, BAM is a radioembolization compound designed to treat a variety of solid organ tumors.
We recently received feedback from the FDA regarding its regulatory designation and the BAM radioembolic product will be regulated as a device, primarily by CDRH. We view this as very good news as the clinical requirements and timeline for approval will be reduced in existing reimbursement paths are already in place. Our 2024 corporate goals for BAM will include specific guidance for development based on FDA -- the FDA regulatory decision. Now in terms of drug production, behind the scenes, we continue to expand and shore up existing supply agreements and work to build in across-the-board supply chain redundancy, including as it relates to isotope availability. As we complete new agreements or relationships, we will communicate those. And with that, I'll turn the call over to our Chief Financial Officer, Andrew Sims, who will review the financials.
Andrew?
Andrew Sims: Thank you, Marc. Good afternoon, everyone. Please refer to our press release issued earlier today for a summary of our financial results for the third quarter ended September 30, 2023. As of September 30, 2023, cash and cash equivalents were $11 million, which is in line with the balance at June 30, 2023. In addition, as of today, Plus has met the requirements to receive the next cash advance from CPRIT of $3.3 million, which we expect to receive prior to reporting our 2023 full year results. Plus also remains on track to receive additional advances in 2024, amounting to a further [Technical Difficulty] to a total of $10.2 million incremental non-dilutive cash grant funding is expected between today and December 31, 2024 from CPRIT.
In addition, the company continues to benefit from the 3 million grant from the NIH to support the GBM trial through Phase II, which is expected to be fully utilized by the end of 2024 to coincide with the completion of the ongoing Phase II trial. Based on the cash on hand and committed grant funding, our current balance sheet provides runway well into 2025. In addition, the company continues to be aggressive in the pursuit of additional NIH and separate grants to support both our current and planned future programs. Our practice will be to continue to announce those upon award. The company recognized $1.2 million of grant revenue in the third quarter of 2023 and $3.6 million year-to-date 2023. The company forecasts grant revenue of between $1 million to $1.5 million in Q4 2023 and between $6 million to $7 million for calendar year 2024.
Total operating expenses for the third quarter of 2023 decreased by $0.7 million to $4.5 million in 2023. Compared to total operating expenses of $5.2 million for the same period the prior year. The decrease is due primarily to the completion of the CGMP drug development in 2022. Other income totalling 32,000 for the quarter includes 119,000 of interest income, which fully offsets the interest expense on the remaining principal on the Oxford debt. So with the grant support our existing go-forward burn is close to 500,000 over the next 18 months. Net loss for the third quarter of 2023 was $3.2 million or $1 per share compared to a net loss of $5.2 million or $2.85 per share for the same period of the prior year. Now I'll turn it back to you Marc.
Marc Hedrick: Thank you, Andrew. Before we move on to Q&A, I'll take a moment to provide guidance on anticipated milestones over the next 14 months. First of all, in Q4, we have multiple presentations accepted at the SNO Annual Meeting, November 15 to 19 in Vancouver. We're particularly excited to present the first data cut from the ongoing Phase II GBM trial to be accompanied [Technical Difficlty] at our thought leader panel and we'll put out the specifics about that panel when finalized. Also the SNO annual meeting in November, we will also have an update on our LM trial as well. Looking beyond the SNO meeting and looking forward into 2024, we intend to complete enrollment in the Phase II ReSPECT-GBM trial and finalize a pivotal trial design with the FDA.
We also intend to complete enrollment in the Phase I ReSPECT-LM trial and begin the Phase II trial. We also intend to complete internal implementation of the CNSide cerebrospinal fluid tumor cell enumeration assay that has been currently utilized in the ReSPECT-LM clinical trial. We intend to obtain FDA IND approval and initiate the Phase I ReSPECT pediatric brain cancer trial for pediatric patients with ependymoma and high-grade glioma at the Lurie Children's Hospital in Chicago. We also will complete key development milestones for the company's next-generation radioembolic device, 188RNL-BAM. At a key second source, GMP supply chain partner to support late stage clinical trials of commercial supply and publish the ReSPECT-GBM Phase I data in a peer-reviewed publication.
Now with that I'll turn it back to Tawanda, the operator for our Q&A session.
Operator: Thank you. [Operator Instructions] Our first question comes from the line of Justin Walsh with Jones Trading. Your line is open.
Justin Walsh: Hi. Thanks for taking the questions and congrats on the progress. I’m wondering if you can provide any color on what we can expect from the presentations at SNO? I know you mentioned survival data for 15 patients, but if there’s any other info you can close ahead of the release and maybe remind us of how many patients’ worth of data we saw last time you guys presented?
Marc Hedrick: Hey, Justin, last time we presented data, there were 34 patients at a high level, 34 total patients treated in the trial. We have five abstracts accepted. Besides presenting the Phase II data set from a safety and efficacy perspective, one novel thing we’ll show is some pretty substantial updated imaging data, and that will be part of the presentation. So this will be across multiple presentations. I can’t really say any more than that as we continue to review the data. But one reason we’re having a thought leader panel is we’ll be able to bring a lot of that data that will be novel and put it into context with some of the investigators that are actually involved in patient care.
Justin Walsh: Great. Really looking forward to all that. So one more question for me. Obviously, there’s been some building momentum in the radiopharma field with M&A activity and some key data releases. Wondering if you’ve seen an increase in interest in your ongoing trials from perspective of patients, physicians and investors.
Marc Hedrick: Yes. So we’ve seen a lot of interest in our CNS radiotherapeutic assets. And I think there are several reasons for that. You mentioned one, which is there’s a renewed interest generally speaking, in the radiotherapeutic space. And Dr. LaFrance, who’s sitting with me today has been in the space for a while. And I think would tell you that it’s been a remarkable increase in interest over the last few years that he’s seen. The second thing is in the radiotherapeutic space, there’s a lot of work at preclinical. There are a number of very successful products and deals that have been announced. But there is a relative dearth of mid-stage assets. And I think that’s one reason we’ve seen a lot of interest in our technology and that we have an ongoing Phase II in GBM.
A very big indication and also LM, which is rapidly getting through the Phase I to Phase II. So that’s I think that’s created a lot of interest. And then finally, just the data itself. These are unmet medical needs that carry very high levels of mortality. There’s nothing approved for LM and there’s only been one approved drug for GBM in the last 10 years, which doesn’t improve survival. It just improves the symptomatology. So I think the combination of those three things has really created a lot of renewed interest in this space.
Justin Walsh: Great. Thanks for taking the questions.
Operator: Thank you. Please standby for our next question. Our next question comes from the line of Sean Lee with H.C. Wainwright. Your line is open.
Sean Lee: Good afternoon, guys, and thanks for taking my questions. First one, during the prepared remarks, you mentioned that the FDA requested additional info from both your existing studies and also for the upcoming pediatric study. Could you provide a bit more information on what was requested.
Marc Hedrick: Norman, would you like to take that?
Norman LaFrance: Hi, Sean. Thanks for the question. The FDA has always liked our approach for the dose escalation in pediatric tumors, which, as everyone knows, are not the same as adult tumors. And our plan is to do a dose escalation, not only an administered dose, but in volume. But as part of that, and as folks know FDA is very conservative, particularly around pediatric dosimetry and radiation treatment. As Marc has mentioned, we have a very well-established pulmonary database in the GBM adult trial. And what we did with FDA is review the adult dosimetry trial, review the adult safety data, which is very well tolerated and quite benign and pointing out to FDA that the — it will be an identical product administered in an identical way with the CED catheters has been quite a success story in adults.
When they got that information, they were very satisfied. We have an agreement to move forward in the protocol design and are just finishing up some minor clarifications with them, which we’ll do this quarter and to that point, we expect to start the pediatric trial early next year.
Sean Lee: Great. Thank you. That makes it much clearer. My second question is on the funding side. You mentioned that approximately $10 million additional for CPRIT next year as well, $3 million for NIH. Would that cover the majority of the expected Phase II study expenses for next year?
Andrew Sims: Thanks, Sean. So the short answer is yes. So separate funds, so let me just kind of give you a background of CPRIT then the timing. So CPRIT funds, two-thirds of all costs relating to the study. So which makes the grant extremely attractive, obviously. Currently, they cover effectively the majority of the third-party development costs, patient costs, drug costs, site initiation fees, et cetera, regulatory costs. And then they also cover significant internal costs, salaries and other overhead rent, IT, et cetera. And as we look forward and I kind of mentioned we would — we should receive over $10.2 million over the next 15 months that will cover just under 70% of the total costs.
Sean Lee: Great. My last question is just on the dose escalation study. I know previously you guys weren’t sure whether the current cohort will be the highest cohort. So I was wondering, would you go even higher in that study? And also what’s, remember, you guys also mentioned that you had a protocol for retreating patients. Is that also planned for a different cohort?
Marc Hedrick: Hi, Sean, it’s Marc. On the first question where we’ve got another couple of patients to complete 6 in cohort 8. We’re at very high radiation doses and volumes. And we’ll have to look at the data. But my guess is we won’t get to a maximum tolerated dose, but we very likely will get to a maximum feasible dose. And so data will be analyzed primarily for safety and distribution. So anyway that’s ongoing. As it relates to retreatment, so we’re in the process of putting a retreatment arm in all of our GBM sites with the idea that — and I don’t want to say too much and pre-empt some of the data at SNO. But we’re going to show imaging data that I think will be very interesting and we’ll can help provide a road map for achieving what is our primary corporate goal and that’s to turn CNS cancers into a chronic disease.
I will say that as it relates to the Phase II, if I can just editorialize a minute that I think we’re on track to complete the single administration Phase II by the end of 2024. If that data continues to look positive, we’ll present that data in the first pass of that at SNO. We may actually seek a pre-end of Phase II meeting with the FDA to discuss options for.
Sean Lee: Great. That’s all I have and thanks again for taking my questions.
Operator: Thank you. Please standby for our next question. Our next question comes from the line of Edward Woo with Ascendiant Capital. Your line is open.
Edward Woo: Yeah, congratulations on the progress. To clarify you said that Cohort 4 the LM trial was the fastest that you were able to get it filled. Is that something that you should expect going forward and does that speed up your time line at all with LM trial?
Norman LaFrance: Hi, Ed. This is Norman. Great question. And the — as I think we’ve discussed previously, there are protocol defined up [Technical Difficulty] that we agreed to with FDA because this is first-in-man intrathecal administration of, obviously, the radio activity. Given the interest that Marc alluded to earlier and a question on an earlier Q&A question, we’re getting a lot of interest on folks for the exact reason Marc mentioned that, first of all, there are really no treatments for this devastating complication. And there really are no significant active investigative trials other than ours. And we’ve gotten a very promising provocative efficacy signal in addition to being a very well-tolerated outpatient treatment.
So the short of it for the Cohorts now five through seven to be continued. We’d expect to enroll at the same rate. With that, we’d expect if there are no DLTs or other safety observations that may call the decision to end in an earlier Cohort, say, Cohort 6 will complete the full dose escalation probably by June of next year. With that, we’ll go to FDA and have an end of Phase I dose escalation and Pre-Phase II meeting and I don’t want to get too forward-looking. But given the current trend of both the safety, tolerability and preliminary efficacy will be in a position to talk to FDA about a Phase II trial that will include it being [Technical Difficulty] leading to an accelerated approval all because LM has no treatment options, is a devastating complication and not a lot of investigative.
At this point, I’ll stop there, and see if you have any other questions.
Edward Woo: Thank you very much. That was very helpful. I wish you guys good luck. Thank you.
Operator: Thank you. Please standby for our next question. Our next question comes from the line of Jason McCarthy with Maxim Group. Your line is open.
Unidentified Analyst: Hi, guys. It’s Chad on for Jason. Sorry if it was already covered, but I was just wondering what the plans are for implementing CNSide in the LM study given that Biocept has declared bankruptcy, will you still be able to use the platform?
Marc Hedrick: Hi, Chad. Yes. So you’re right. They declared bankruptcy. We’ve been using the test for over a year and I did mention a bit in my prepared remarks, but I’ll expand on those. We didn’t really know what to expect. We started using the trial, the test, but over a year or so of experienced both with our technology and our trial and talking to the investigators, we think there’s a real opportunity with this test. We were concerned about them their solvency over the past year. And that’s why we, frankly, licensed and transferred the technology to ourselves in the weeks before they declared insolvency. So we essentially have a nonexclusive right to use the test for — in our trials with our technology and then we have an option that’s exercisable through the end of next year to gain exclusivity in the area of radiotherapeutics for this test.
So now that they’re gone, and they are gone, they’re no longer operating. We’ll be taking the protocols, the information and the testing kits that we have already acquired and are now in Texas and we’ll begin using the test, not in a CLIA fashion, but just as a research tool, so we can use in the context of our trial. Now with our option based on kind of our ongoing experience, we will actually consider whether we want to exercise that and maybe expand that. But right now, I think, the plan is just to implement it and use it in our trial and frankly CPRIT ought to pay for that as well.
Unidentified Analyst: Okay. Great. Thanks for taking the question and congrats on the progress.
Marc Hedrick: Okay. Thank you.
Operator: Thank you. I’m showing no further questions in the queue. I would now like to turn the call back over to Marc for closing remarks.
Marc Hedrick: Thank you, Tawanda. Thanks, everyone for joining us. Thanks for the good questions. Thanks for your interest in the company and we will be talking to you soon. Have a nice evening. Goodbye.
Operator: Ladies and gentlemen, this concludes today’s conference call. Thank you for your participation. You may now disconnect.
Hot Features
プレミアム
登録して、同じ考えを持つ投資家と議論するためのアクティブなフォーラムで相互作用するためのアクティブなフォーラムに参加してください。
glenn1919
2月前
Monksdream
6月前
TimeFades
1年前
