Shuttle Pharmaceuticals reports 25% enrollment in Phase 2 glioblastoma trial for Ropidoxuridine, aimed at enhancing radiation therapy outcomes.
Quiver AI Summary
Shuttle Pharmaceuticals Holdings, Inc. has reported that it has reached 25% enrollment in the initial randomized section of its Phase 2 Clinical Trial for Ropidoxuridine, aimed at treating glioblastoma patients. The trial will initially enroll 40 patients to assess two different dosing levels before determining the optimal dosage for further testing. Currently, glioblastoma patients primarily receive radiation as their standard treatment, with less than half surviving beyond 12 months after diagnosis. Ropidoxuridine is being developed as a radiation sensitizer to enhance the effectiveness of radiation therapy for these patients, and the trial is ongoing at several prominent cancer centers. Shuttle Pharma has also received Orphan Drug Designation from the FDA for this treatment, which could provide marketing exclusivity if approved. CEO Anatoly Dritschilo expressed gratitude to the participating cancer centers for their contributions to the trial.
Potential Positives
- Shuttle Pharmaceuticals has achieved 25% enrollment in its Phase 2 Clinical Trial of Ropidoxuridine, indicating strong progress in its research efforts for treating glioblastoma.
- The trial's focus on glioblastoma, a highly aggressive brain tumor with limited treatment options, highlights the company's commitment to addressing critical unmet medical needs.
- Ropidoxuridine has received Orphan Drug Designation from the FDA, which could provide the company with significant commercial advantages and exclusivity upon approval.
- The company is conducting the trial in collaboration with several prestigious cancer centers, enhancing its credibility and potential for attracting further partnerships and funding.
Potential Negatives
- The press release heavily emphasizes the potential of Ropidoxuridine while not providing any concrete results from the ongoing Phase 2 trial, which may raise skepticism about the efficacy of the treatment.
- Despite achieving 25% enrollment, the fact that this is only the initial portion of the trial implies that the study is still in its early stages, suggesting that significant uncertainties remain regarding the timing and outcome of the trial.
- There is a strong reliance on forward-looking statements, presenting inherent risks that could affect the company's performance and stakeholder confidence, as highlighted in the Safe Harbor Statement.
FAQ
What is Shuttle Pharmaceuticals' recent announcement about?
Shuttle Pharmaceuticals announced achieving 25% enrollment in its Phase 2 clinical trial for Ropidoxuridine to treat glioblastoma patients.
What is the purpose of the Phase 2 clinical trial?
The trial aims to determine the optimal dose of Ropidoxuridine for glioblastoma patients undergoing radiation therapy.
What is Ropidoxuridine used for?
Ropidoxuridine is being developed as a radiation sensitizer to enhance the effectiveness of radiation therapy for glioblastoma.
Where is the clinical trial being conducted?
The trial is conducted at several cancer centers including Georgetown University Medical Center and UNC Medical Center.
What is the future outlook for cancer patients treated with radiation therapy?
Shuttle Pharma aims to improve patient survival and quality of life through the development of effective radiation sensitizers.
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.
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Full Release
GAITHERSBURG, Md., Jan. 21, 2025 (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 it has achieved 25% enrollment in the initial randomized portion of its Phase 2 Clinical Trial of Ropidoxuridine for the treatment of patients with glioblastoma.
The Phase 2 trial design is to initially randomize 40 patients into two different dose levels, with 20 patients receiving 1,200 mg/day and 20 patients receiving 960 mg/day, to determine an optimal dose for use in glioblastoma patients. Once the optimal dose is identified, 14 additional patients will be enrolled at the optimal dose to reach statistical significance with the end-point demonstrating survival as compared to historical controls. The Phase 2 clinical trial is being conducted on patients presenting with the most aggressive form of brain tumors– IDH wild-type, methylation negative glioblastoma. This cohort of patients currently only have radiation as the standard of care, with less than half of the patients surviving beyond 12 months after diagnosis.
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 Pharma previously received Orphan Drug Designation from the FDA, providing Shuttle Pharma with potential marketing exclusivity upon obtaining FDA approval for treatment of this disease.
The Phase 2 trial is conducted at 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.
“Enrollment into the trial is ahead of our expectations,” commented Shuttle Pharma's CEO and Chairman, Anatoly Dritschilo, M.D. “I am grateful to the teams at each of these nationally recognized cancer centers for their participation in the trial as we look to develop 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 palliative 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 .
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. The reader is cautioned not to rely on such forward-looking statements. Such forward-looking statements relate to future events or our future performance. In evaluating these forward-looking statements, you should consider various factors, including our expectations regarding the success and/or completion of our Phase 2 clinical trials; our success in completing any newly initiated clinical trials, commence new trials and obtain regulatory approval following such trials; challenges and uncertainties inherent in product research and development; and the uncertainty regarding future commercial success. These and other factors may cause our actual results to differ materially from any forward-looking statements. Forward-looking statements are only predictions and 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, 2023, as amended, filed with the SEC on September 4, 2024, 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
Anatoly Dritschilo, M.D., CEO
240-403-4212
[email protected]
Investor Contacts
Lytham Partners, LLC
Robert Blum
602-889-9700
[email protected]
