Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) has completed enrollment agreements with all six planned clinical trial sites for the Phase 2 clinical trial of Ropidoxuridine (IPdR) in patients with glioblastoma. The agreements include Georgetown University Medical Center and UNC Medical Center, joining previously secured sites such as UVA Cancer Center and John Theurer Cancer Center.
The Phase 2 clinical trial (NCT06359379) is enrolling patients with aggressive, IDH wild-type, methylation negative glioblastomas. Radiation therapy is the standard of care for this patient population, but historical outcome studies show that over half of these patients live less than 12 months after diagnosis. The trial will randomize 40 patients into two different dose groups (20 at 1,200 mg/day and 20 at 960 mg/day) to determine an optimal dose. An additional 14 patients will then be added to the optimal dosage group to reach the survival end-point for comparison to historical controls. The company anticipates the trial will be completed in the next 18 to 24 months.
Ropidoxuridine: A Radiation Sensitizer
Ropidoxuridine is Shuttle Pharma's lead candidate as a radiation sensitizer, designed to enhance the effectiveness of radiation therapy (RT) in treating brain tumors, specifically glioblastoma. This aggressive brain cancer currently has no known cure. The FDA has granted Orphan Drug Designation to Ropidoxuridine, which could provide marketing exclusivity upon FDA approval for this indication.
Trial Design and Objectives
The Phase 2 trial is a randomized study evaluating two different doses of Ropidoxuridine in combination with radiation therapy. The primary endpoint is to determine the optimal dose of Ropidoxuridine. Secondary endpoints include assessing the impact on patient survival compared to historical controls. Patients being screened have signed consents for treatment and are undergoing evaluation for enrollment.
Market Opportunity
According to Shuttle Pharma's CEO, Anatoly Dritschilo, M.D., approximately 800,000 patients in the U.S. receive radiation therapy annually, with about 50% receiving it with curative intent. Dr. Dritschilo stated, "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."
About Shuttle Pharma
Shuttle Pharma, founded in 2012 by faculty members of Georgetown University Medical Center, focuses on developing therapies to improve outcomes for cancer patients treated with radiation therapy. The company's mission is to maximize the effectiveness of RT while limiting radiation's side effects. Shuttle Pharma aims to increase cancer cure rates, prolong patient survival, and improve quality of life through radiation sensitizers, used alone or with surgery, chemotherapy, and immunotherapy.
