Shuttle Pharma Reaches Milestone in Patient Enrollment for Phase 2 Clinical Trial of Ropidoxuridine for Treatment of Patients with Glioblastoma
Rhea-AI Summary
Shuttle Pharmaceuticals Holdings (SHPH) has reached 25% enrollment in the initial randomized portion of its Phase 2 Clinical Trial of Ropidoxuridine for glioblastoma treatment. The trial design involves randomizing 40 patients into two dose levels: 1,200 mg/day and 960 mg/day, followed by enrolling 14 additional patients at the optimal dose.
The trial focuses on patients with IDH wild-type, methylation negative glioblastoma, where currently less than half survive beyond 12 months after diagnosis. The study is being conducted at six nationally recognized cancer centers. Ropidoxuridine, Shuttle Pharma's lead radiation sensitizer candidate, has received FDA Orphan Drug Designation.
The company aims to serve an estimated 400,000 US patients treated with radiation therapy for curative purposes annually, with this market expected to grow by 22% over the next five years.
AI-generated analysis. Not financial advice.
Positive
- Achieved 25% enrollment in Phase 2 Clinical Trial ahead of expectations
- FDA Orphan Drug Designation secured, providing potential marketing exclusivity
- Trial conducted across six major national cancer centers
- Large addressable market of 400,000 patients with 22% growth expected in 5 years
Negative
- None.
News Market Reaction – SHPH
On the day this news was published, SHPH gained 4.76%, reflecting a moderate positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
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
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
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
info@shuttlepharma.com
Investor Contacts
Lytham Partners, LLC
Robert Blum
602-889-9700
shph@lythampartners.com
