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 cases
The 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,
LLCCNSide 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 TestThe 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 TherapeuticsPlus
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 StatementsThis 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 ContactCharles Y.
Huang, MBADirector of Capital Markets and Investor RelationsOffice:
(202)-209-5751 | Direct
(301)-728-7222chuang@plustherapeutics.com
Plus Therapeutics (NASDAQ:PSTV)
過去 株価チャート
から 11 2024 まで 12 2024
Plus Therapeutics (NASDAQ:PSTV)
過去 株価チャート
から 12 2023 まで 12 2024