AveragePenny
4日前
$SHPH Shuttle Pharma Provides Third Quarter 2024 Corporate Update
https://www.globenewswire.com/news-release/2024/11/13/2980735/0/en/Shuttle-Pharma-Provides-Third-Quarter-2024-Corporate-Update.html
GAITHERSBURG, Md., Nov. 13, 2024 (GLOBE NEWSWIRE) -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle Pharma” or the “Company”), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT), today provided a corporate update in connection with the filing of its Quarterly Report on Form 10-Q for the third quarter ended September 30, 2024.
Shuttle Pharma’s recent highlights include the following:
Successfully dosed first three patients in the Phase 2 clinical trial of Ropidoxuridine for the treatment of patients with brain tumors (glioblastoma). Ropidoxuridine is Shuttle Pharma's lead candidate radiation sensitizer for use in combination with RT to treat glioblastoma, a deadly malignancy of the brain with no known cure. Additional patients are currently undergoing screening for enrollment in the trial.
Finalized agreements with all six of the planned site enrollment locations which will be administering the Phase 2 clinical trial following the Company’s entry into agreements with Georgetown University Medical Center and UNC Medical Center. The Company previously entered agreements with the UVA Cancer Center, John Theurer Cancer Center at Hackensack University Medical Center, Allegheny Health Network (AHN) Cancer Institute, and Miami Cancer Institute, part of Baptist Health South Florida.
Paid off the entirety of the outstanding balance due under Shuttle Pharma’s Senior Secured Convertible Note issued on January 11, 2023. The initial balance of the Note was $4.3 million and was originally repayable over a 26-month period ending March 11, 2025.
Completed a $4.5 million public offering priced At-The-Market under Nasdaq rules. The Company intends to use the net proceeds from this offering to fund IND-enabling and Phase 1 and 2 clinical trials of product candidates, including payments that will be made to the clinical research organization supporting the Phase 2 clinical trial for Ropidoxuridine, and for working capital and general corporate purposes.
The Company also closed on a convertible note and warrant offering, receiving a total of $790,000 in gross proceeds, including $237,500 invested by the Company’s Chief Executive Officer, Dr. Anatoly Dritschilo.
Cash balance as of October 31, 2024 was $4.1 million.
“We made tremendous progress over the past few months to advance our Phase 2 clinical trial of Ropidoxuridine for the treatment of patients with glioblastoma, with the first three patients dosed in October 2024,” stated Shuttle Pharma’s Chairman and CEO, Anatoly Dritschilo, M.D. “The initial patient dosing followed the successful engagement of all six of the planned clinical trial site locations, each of which are nationally recognized cancer centers that are most likely to treat IDH wild-type, methylation negative glioblastoma patients – the target of the clinical trial. The initiation of the Phase 2 trial is a significant milestone for both Shuttle Pharma and the thousands of patients with brain tumors who currently lack effective therapies.”
“Beyond these critical clinical developments, we also made progress in improving our balance sheet and funding the Phase 2 clinical trial. I want to thank all of the investors who have committed to helping us advance our mission to leverage radiation sensitizers to increase cancer cure rates, prolong patient survival and improve quality of life for patients suffering from glioblastoma,” Dr. Dritschilo concluded.
AveragePenny
3週前
$SHPH Shuttle Pharma Pays Off Senior Secured Convertible Note
https://www.globenewswire.com/en/news-release/2024/10/29/2971226/0/en/Shuttle-Pharma-Pays-Off-Senior-Secured-Convertible-Note.html
GAITHERSBURG, Md., Oct. 29, 2024 (GLOBE NEWSWIRE) -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle Pharma”), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT), today announced that, during the third quarter of this year, it paid off the entirety of the outstanding balance due under its Senior Secured Convertible Note (“Note”) issued on January 11, 2023.
The initial balance of the Note was $4.3 million and was originally repayable over a 26-month period ending March 11, 2025. During the term of the note, Shuttle Pharma made periodic cash payments totaling $1.3 million and equity issuances totaling 1,094,970 shares (on a post reverse split basis). As a result, the Company now has a total of 2,946,099 shares outstanding. Additionally, in October 2024, Shuttle Pharma closed on a convertible note and warrant offering, receiving a total of $790,000 in gross proceeds, including $237,500 invested by the Company’s Chief Executive Officer, Dr. Anatoly Dritschilo.
“The elimination of the convertible note along with obtaining the bridge funding provides us with added flexibility to advance our ongoing Phase 2 clinical trial for the treatment of patients with glioblastoma,” commented Shuttle Pharma's Chairman and CEO, Anatoly Dritschilo, M.D. “Over the past few months, Shuttle Pharma has made progress on a number of key activities. Along with our paydown of the convertible note and raising interim bridge funding, we have entered into agreements with six trial sites, five of which are now fully prepared to begin treating patients in the Phase 2 clinical trial. I look forward to maintaining our focus towards achieving our goal of increasing cancer cure rates, prolonging patient survival, and improving the quality of life for patients suffering from glioblastoma.”
The Phase 2 clinical trial has begun enrolling patients with the most aggressive brain tumors out there – IDH wild-type, methylation negative glioblastoma. Presently, radiation is the only approved standard of care for this particular group of patients, with more than half of the patients surviving for less than 12 months after diagnosis. Shuttle Pharma’s Phase 2 clinical trial will consist initially of 40 patients randomized into two different doses (20 @ 1,200 mg/day and 20 @ 960 mg/day) to determine an optimal dose. Once the Company determines the optimal dose, it will then add an additional 14 patients on the optimal dosage allowing for the achievement of statistical significance with the end point being that of survival as compared to historical controls. The Company expects the trial to be completed over a period of 18 to 24 months.
An estimated 800,000 patients in the US are treated with radiation therapy for their cancers yearly. According to the American Cancer Society and the American Society of Radiation Oncologists, about 50% are treated for curative purposes and the balance for therapeutic care. The market opportunity for radiation sensitizers lies with the 400,000 patients treated for curative purposes, with this number expected to grow by more than 22% over the next five years.
AveragePenny
3週前
$SHPH Shuttle Pharmaceuticals Holdings, Inc. Announces Pricing of $4.5 Million Public Offering Priced At-The-Market Under Nasdaq Rules
https://www.globenewswire.com/en/news-release/2024/10/30/2971356/0/en/Shuttle-Pharmaceuticals-Holdings-Inc-Announces-Pricing-of-4-5-Million-Public-Offering-Priced-At-The-Market-Under-Nasdaq-Rules.html
GAITHERSBURG, Md., Oct. 29, 2024 (GLOBE NEWSWIRE) -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle Pharma” or the “Company”), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT), today announced the pricing of its "reasonable best efforts" public offering with a health-care focused institutional investor for the purchase and sale of up to 2,950,820 shares of common stock (or pre-funded warrants in lieu thereof) and warrants to purchase up to 2,950,820 shares of common stock at a combined offering price of $1.525 per share and accompanying warrant, priced at-the-market under Nasdaq rules (the “Offering”). The Company expects to receive aggregate gross proceeds of approximately $4.5 million, before deducting placement agent fees and other offering expenses, and assuming no exercise of the warrants. The warrants will have an exercise price of $1.40 per share, will be exercisable immediately and will expire five years from the issuance date.
The closing of the Offering is expected to occur on or about October 31, 2024, subject to the satisfaction of customary closing conditions. The Company intends to use the net proceeds from this Offering to fund IND-enabling and Phase I and II clinical trials of product candidates, including $2.3 million in payments that will be owed to Theradex Systems, Inc., the clinical research organization (CRO) supporting Shuttle Pharma’s Phase II clinical trials for radiation sensitizer Ropidoxuridine, and for working capital and general corporate purposes.
A.G.P./Alliance Global Partners is acting as the lead placement agent for the Offering and Boustead Securities, LLC is acting as a co-placement agent for the Offering.
AveragePenny
3週前
$SHPH Shuttle Pharma Doses First Patients in Phase 2 Clinical Trial of Ropidoxuridine for Treatment of Patients with Glioblastoma
https://www.globenewswire.com/en/news-release/2024/10/29/2970880/0/en/Shuttle-Pharma-Doses-First-Patients-in-Phase-2-Clinical-Trial-of-Ropidoxuridine-for-Treatment-of-Patients-with-Glioblastoma.html
GAITHERSBURG, Md., Oct. 29, 2024 (GLOBE NEWSWIRE) -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle Pharma”), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT), announced today that the first three patients in its Phase 2 Clinical Trial of Ropidoxuridine for the treatment of patients with glioblastoma have been successfully dosed.
Ropidoxuridine (IPdR) is Shuttle Pharma's lead candidate radiation sensitizer for use in combination with RT to treat brain tumors (glioblastoma), a deadly malignancy of the brain with no known cure. Shuttle has received Orphan Drug Designation from the FDA, providing potential marketing exclusivity upon first FDA approval for the disease.
The Phase 2 clinical trial will be conducted with the most aggressive brain tumors out there – IDH wild-type, methylation negative glioblastoma patients. This particular group of patients at this time only have radiation as the standard of care, with more than half of the patients surviving for less than 12 months after diagnosis. The Phase 2 trial will consist initially of 40 patients randomized into two different doses (20 @ 1,200 mg/day and 20 @ 960 mg/day) to determine an optimal dose. Once the Company determines the optimal dose, it will then add an additional 14 patients on the optimal dose allowing for the achievement of statistical significance with the end point being that of survival compared to historical controls. The Company expects the trial to be completed over a period of 18 to 24 months.
“The initiation of patient dosing in our Phase 2 trial of Ropidoxuridine for the treatment of patients with glioblastoma is a significant milestone for both Shuttle Pharma and the thousands of patients with brain tumors who currently lack effective therapies,” commented Shuttle Pharma's Chairman and CEO, Anatoly Dritschilo, M.D. “The results of this trial will be important as Shuttle Pharma looks to leverage radiation sensitizers to increase cancer cure rates, prolong patient survival and improve quality of life for patients suffering from glioblastoma.”
An estimated 800,000 patients in the US are treated with radiation therapy for their cancers yearly. According to the American Cancer Society and the American Society of Radiation Oncologists, about 50% are treated for curative purposes and the balance for therapeutic care. The market opportunity for radiation sensitizers lies with the 400,000 patients treated for curative purposes, with this number expected to grow by more than 22% over the next five years.
More information about the Phase 2 study (NCT06359379) can be found at www.clinicaltrials.gov.
subslover
3週前
Shuttle Pharma Completes Clinical Trial Site Enrollment for Phase 2 of Ropidoxuridine for Treatment of Patients with Glioblastoma
GAITHERSBURG, Md., Oct. 28, 2024 (GLOBE NEWSWIRE) -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle Pharma”), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT), announced today it has finalized agreements with all six of the planned site enrollment locations to administer the Phase 2 clinical trial of Ropidoxuridine for the treatment of patients with glioblastoma following the entry into agreements with Georgetown University Medical Center and UNC Medical Center. The Company previously entered agreements with UVA Cancer Center, John Theurer Cancer Center at Hackensack University Medical Center, Allegheny Health Network (AHN) Cancer Institute, and Miami Cancer Institute, part of Baptist Health South Florida. Patients are currently undergoing screening for enrollment in the trial.
Ropidoxuridine (IPdR) is Shuttle Pharma's lead candidate radiation sensitizer for use in combination with RT to treat brain tumors (glioblastoma), a deadly malignancy of the brain with no known cure. Shuttle has received Orphan Drug Designation from the FDA for IPdR, providing potential marketing exclusivity upon first FDA approval for treatment of the disease.
“We have successfully engaged all six of the planned clinical trial site locations to administer the Phase 2 clinical trial of Ropidoxuridine,” commented Shuttle Pharma's CEO, Anatoly Dritschilo, M.D. “All six locations are nationally recognized cancer centers that are most likely to treat IDH wild-type, methylation negative glioblastoma patients, the target of the clinical trial. Patients are currently being evaluated for enrollment, having signed consents for treatment, and are now in the process of being screened.”
The Phase 2 clinical trial has begun enrolling patients with aggressive, IDH wild-type, methylation negative glioblastomas. Presently, radiation is the standard of care for this particular group of patients, but outcome studies have shown that more than half of the patients live for less than 12 months after diagnosis. Shuttle Pharma’s Phase 2 clinical trial will randomize 40 patients into two different dose groups (20 @ 1,200 mg/day and 20 @ 960 mg/day) to determine an optimal dose, which will then be continued to add 14 patients on the optimal dosage to reach the survival end-point for comparison to historical controls. The Company expects the trial to be completed over the next 18 to 24 months.
Dr. Dritschilo continued, “An estimated 800,000 patients in the U.S. are treated with radiation therapy annually. According to the American Cancer Society and the American Society of Radiation Oncologists, about 50% of those patients receive radiation therapy with curative intent. The market opportunity for radiation sensitizers lies with the 400,000 patients treated to achieve cancer cures. The results of this trial will be important to the cancer community as we look for effective radiation sensitizers to increase cancer cure rates, prolong patient survival and improve quality of life for patients suffering from glioblastoma.”
More information about the Phase 2 study (NCT06359379) can be found at www.clinicaltrials.gov.
konshe
1年前
news out today:
Shuttle Pharmaceuticals Holdings, Inc. (NASDAQ:SHPH), a discovery and development stage specialty pharmaceutical company focused on improving the outcomes of cancer patients treated with radiation therapy (RT), today announced that TCG GreenChem has successfully completed the initial manufacturing campaign for the active pharmaceutical ingredient (API) of Ropidoxuridine for use in the Company's upcoming Phase II clinical trial in brain cancer patients undergoing radiation therapy.
"Shuttle has been working concomitantly with TCG GreenChem to manufacture API and University of Iowa Pharmaceuticals to develop the formulation and packaging of the drug product into capsules for clinical use. Today's announcement of successfully completing the API manufacturing is an important step in the advancement Ropidoxuridine, our lead clinical sensitizer drug candidate, towards the commencement of our upcoming Phase II clinical trial in brain cancer patients undergoing radiation therapy," commented Shuttle Pharma's Chairman and CEO, Anatoly Dritschilo, M.D.
In addition, Shuttle's recent request for a Type B pre-IND meeting with the FDA for guidance on the proposed Phase II clinical trial has been approved with a goal of receiving written responses from the FDA by September 18, 2023. With this, the Company believes it remains on track to commence its Phase II clinical study in the fourth quarter of 2023.
konshe
1年前
Shuttle Pharmaceuticals Provides Q1 2023 Corporate Update
3w
+2.88%
Recent Highlights
Shuttle Pharma continues to execute on the necessary steps to advance Ropidoxuridine, the Company's lead clinical sensitizer drug candidate, towards the commencement of its upcoming Phase II clinical trial in brain cancer patients undergoing radiation therapy with an expectation of pre-IND application submission to the FDA by the end of the second quarter of 2023.
Entered into agreements with TCG GreenChem, Inc. and UI Pharmaceuticals for drug manufacture and formulation development of Ropidoxuridine, the Company's lead clinical sensitizer drug candidate, for use in the Company's upcoming Phase II clinical trial evaluating Ropidoxuridine in combination with radiation therapy for the treatment of glioblastoma.
Engaged Theradex Oncology, a leading clinical research organization, to help prepare for its upcoming clinical study of Ropidoxuridine.
Entered into an agreement to lease new laboratory and office space, commencing in June 2023, to assist in furthering the development of the Company's lead drug candidates and accelerate broader diagnostic capabilities on predictive biomarkers.
Entered a research agreement with Georgetown University focused on the evaluation of the Company's lead HDAC6 inhibitor candidate, SP-2-225, evaluating the anti-tumor effect of the combination of SP-2-225 and RT in a syngeneic breast cancer model.
Shuttle Pharma was awarded U.S. Patent No. 11,654,157, "Methods And Compositions For Cancer Therapies That Include Delivery Of Halogenated Thymidines And Thymidine Phosphorylase Inhibitors In Combination With Radiation," which was issued by the U.S. Patent and Trademark Office on May 23, 2023.
Published manuscripts discussing prostate cancer cell lines derived from African American men for precision medicine and immune responses taking place in patients after radiation therapy for cancer.
Awarded patents in the U.S. and Hong Kong for its radiation sensitizing HDAC inhibitor technology platform.
Appointed Dr. Bette Jacobs to its Board of Directors as an independent director.
Rang the Nasdaq opening bell in January 2023.
Closed on private placement of $4.3 Million of Senior Secured Convertible Note and Warrants to purchase 1.018 million shares of common stock in exchange for $4.0 million investment.
At March 31, 2023, the Company had a working capital balance of $9 million. The Company anticipates that it has sufficient capital to fund operations into the first quarter of 2025.
"Shuttle Pharma is advancing our mission to improve the lives of cancer patients by developing therapies that are designed to maximize the effectiveness of Radiation Therapy while limiting the late effects of radiation in cancer treatment," commented Shuttle Pharma's Chairman and CEO, Anatoly Dritschilo, M.D. "During the first quarter, we made tangible progress advancing our pipeline, including Ropidoxuridine, our lead clinical drug candidate, which sensitizes rapidly growing cancer cells and, our various selective HDAC (histone deacetylase) inhibitors – which sensitize cancer cells and stimulate the immune system. With Ropidoxuridine, we are finalizing details to submit the final protocol details to the FDA at the end of the second quarter of 2023 with commencement of the Phase II clinical trial in brain cancer patients commencing shortly thereafter. Additionally, we are advancing pre-clinical work to support our IND-enabling studies in 2023 with a goal to submit an investigational new drug application (IND) for the selective HDAC6 inhibitor and initiation of a Phase I clinical trial in 2024. We look forward to an exciting 2023 as we advance our immuno-oncology and radio-oncology solutions."
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