Shuttle Pharmaceuticals announced progress in glioblastoma trial and advancements in diagnostics and board expansion.
Quiver AI Summary
Shuttle Pharmaceuticals Holdings, Inc. provided a corporate update focusing on their Phase 2 clinical trial for Ropidoxuridine, aimed at treating glioblastoma. Nearly 50% of patient enrollment has been achieved, with 84% completing the treatment regimen. The drug has shown good tolerance among patients, with manageable toxicity levels. The company is analyzing pharmacokinetic and pharmacodynamic samples to optimize dosing, with aims to complete enrollment later this year and report data in 2026. Additionally, Shuttle is advancing its Diagnostics subsidiary through a research agreement with UCSF and has filed a provisional patent for PSMA-targeted cancer therapies. The company has also appointed new board members and strengthened its financial position through a recent public offering, while acknowledging the resignations of key executives.
Potential Positives
- Near completion of patient enrollment in Phase 2 clinical trial of Ropidoxuridine for glioblastoma, achieving nearly 50% enrollment and strong completion rates.
- Successful filing of a provisional patent for a PSMA-targeted therapeutic, indicating progress in innovation and development in cancer treatment.
- Appointment of new board members with expertise in business and legal backgrounds, potentially strengthening governance and strategic direction.
- Strengthened balance sheet following an underwritten public offering, providing additional financial stability for ongoing and future projects.
Potential Negatives
- The resignation of Dr. Anatoly Dritschilo as Chief Scientific Officer and board member could raise concerns about leadership stability and direction, especially in a company focused on drug development.
- The announcement of Michael Vander Hoek's retirement as Vice President, Regulatory, may signal potential regulatory challenges or gaps in expertise at a critical time for the company's clinical trials.
- Despite advancements, the company has only achieved nearly 50% patient enrollment in the Phase 2 clinical trial, potentially indicating challenges in recruitment or interest from patients and sites.
FAQ
What is the focus of Shuttle Pharmaceuticals?
Shuttle Pharmaceuticals is focused on improving outcomes for cancer patients treated with radiation therapy.
What progress has been made in the Ropidoxuridine trial?
Nearly 50% enrollment has been achieved, with 84% of patients completing all seven cycles of the trial.
What is a key highlight of the company’s Diagnostics subsidiary?
They entered a research agreement with UCSF to develop a PSMA-targeted ligand for potential theranostic applications.
Who were the recent additions to Shuttle Pharma's board of directors?
George Scorsis, Oleh Nabyt, and Joseph Tung were appointed to the board, bringing valuable business and legal backgrounds.
What is the company’s financial status as of March 31, 2025?
Shuttle Pharma's cash and cash equivalents were reported at $4.5 million.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
Full Release
GAITHERSBURG, Md., May 15, 2025 (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.
Shuttle Pharma’s recent highlights:
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Phase 2 clinical trial of Ropidoxuridine for treatment of patients with glioblastoma highlights include:
- Patient enrollment nears milestone as nearly 50% enrollment has been achieved in the initial randomized portion of the trial.
- 84% of the enrolled patients have completed all seven cycles.
- Ropidoxuridine is being reported as well tolerated by treatment sites and toxicity is no greater than 2 on a scale of 1-5.
- Analyzing pharmacokinetic/pharmacodynamic samples to compare the relationship between dose and response in terms of the extent and duration of Ropidoxuridine’s action has begun.
- Enrollment continues at nationally recognized cancer centers, including Georgetown University Medical Center, Allegheny Health Network (AHN) Cancer Institute, UNC Medical Center, the UVA Cancer Center, John Theurer Cancer Center at Hackensack University Medical Center, and Miami Cancer Institute, part of Baptist Health South Florida.
- Objective is to finalize enrollment later this year with follow up and data read out in 2026.
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Other key activities include:
- Continued advancement of the Company’s Diagnostics subsidiary through the entry of a sponsored research agreement with the University of California, San Francisco (UCSF) to advance pre-clinical development of a ligand to the prostate-specific membrane antigen (PSMA) as a potential diagnostic and therapeutic, or theranostic, molecule. Theranostic molecules are suitable for diagnosis and therapy of cancers.
- Filed a key provisional patent application with the United States Patent and Trademark Office (USPTO) entitled “PSMA-Targeted PARP Inhibitor Conjugates for Precision Cancer Therapy.” The filing comes through Shuttle Pharma’s collaboration with internationally renowned medicinal chemist, Dr. Alan Kozikowski. Dr. Kozikowski’s original medicinal chemistry research performed in collaboration with Professor Joseph Neale and conducted at Georgetown University Medical Center were a component in the creation of both Pylarify and Pluvitco.
- Appointed three new members to the Company’s board of directors (George Scorsis, Oleh Nabyt and Joseph Tung), offering business and legal backgrounds to help guide the Company going forward.
- Strengthened the Company’s balance sheet through the completion of an underwritten public offering. Cash and cash equivalents at March 31, 2025 were $4.5 million.
“We are thrilled with the progress of our Phase 2 clinical trial for Ropidoxuridine in treating glioblastoma, a devastating brain cancer,” commented Shuttle Pharma's interim Chief Executive Officer, Chris Cooper. “With nearly 50% of patient enrollment achieved in the initial randomized portion and 84% of enrolled patients completing all seven cycles, the trial is advancing steadily at esteemed cancer centers. Ropidoxuridine has been well-tolerated and we have begun analyzing pharmacokinetic and pharmacodynamic samples to optimize dosing and response. Our goal is to complete enrollment later this year, with follow-up and data readouts anticipated in 2026.”
"In parallel, Shuttle Pharma is making significant strides in our Diagnostics subsidiary through a sponsored research agreement with UCSF to develop a PSMA-targeted ligand for potential theranostic applications in prostate cancer. We’ve also filed a provisional patent for 'PSMA-Targeted PARP Inhibitor Conjugates for Precision Cancer Therapy,' in collaboration with Dr. Alan Kozikowski, an internationally renowned medicinal chemist. Additionally, we have enhanced our business focus through the addition of new board members and a strengthened balance sheet through our recent public offering. These actions help prepare us for the accelerated achievement of key milestones in the future.”
On Friday, May 9, 2025, Dr. Anatoly Dritschilo announced his resignation from the Company’s Board of Directors and as Chief Scientific Officer. Additionally, Michael Vander Hoek, the Company’s Vice President, Regulatory, announced his retirement with an effective date of June 10, 2025.
“Finally, I want to thank Dr. Dritschilo and Michael Vander Hoek for their many contributions to Shuttle Pharma since its inception. We look forward to building off the work completed to date to bring us closer to offering hope for patients battling this aggressive disease," Mr. Cooper concluded.
About Shuttle Pharmaceuticals
Founded in 2012 by faculty members of the Georgetown University Medical Center, Shuttle Pharma is a discovery and development stage specialty pharmaceutical company focused on improving the outcomes for cancer patients treated with radiation therapy (RT). Our mission is to improve the lives of cancer patients by developing therapies that are designed to maximize the effectiveness of RT while limiting the side effects of radiation in cancer treatment. Although RT is a proven modality for treating cancers, by developing radiation sensitizers, we aim to increase cancer cure rates, prolong patient survival and improve quality of life when used as a primary treatment or in combination with surgery, chemotherapy and immunotherapy. For more information, please visit our website at www.shuttlepharma.com .
Safe Harbor Statement
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include, but are not limited to, statements concerning the development of our company. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including factors discussed in the “Risk Factors” section of Shuttle Pharma’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on February 26, 2025, as well other SEC filings. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, Shuttle Pharmaceuticals specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
Shuttle Pharmaceuticals
Chris Cooper
Chief Executive Officer
[email protected]
Investor Contacts
Lytham Partners, LLC
Robert Blum
602-889-9700
[email protected]