Shuttle Pharma Completes Enrollment for Phase 2 Ropidoxuridine Glioblastoma Trial
核心洞察
Shuttle Pharma (搜索) finalized agreements with all six planned clinical trial sites for the Phase 2 study of Ropidoxuridine in glioblastoma (搜索) patients.
The Phase 2 trial will randomize 40 patients with IDH wild-type, methylation negative glioblastomas into two different dose groups.
The study aims to determine an optimal dose of Ropidoxuridine and will continue to add 14 patients on the optimal dosage to reach the survival end-point.
Shuttle Pharmaceuticals Holdings, Inc. has completed clinical trial site enrollment for the Phase 2 clinical trial of Ropidoxuridine for the treatment of patients with glioblastoma (搜索). Agreements have been finalized with Georgetown University Medical Center and UNC Medical Center, joining 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.
Ropidoxuridine for Glioblastoma Treatment
Ropidoxuridine (IPdR) is Shuttle Pharma (搜索)’s lead candidate as a radiation sensitizer for use in combination with radiation therapy (RT) to treat brain tumors, specifically glioblastoma (搜索). Glioblastoma is an aggressive brain malignancy with a poor prognosis. Shuttle Pharma has received Orphan Drug Designation from the FDA for IPdR, which could provide marketing exclusivity upon FDA approval for this indication.
According to Shuttle Pharma (搜索)’s CEO, Anatoly Dritschilo, M.D., all six clinical trial site locations are nationally recognized cancer centers likely to treat IDH wild-type, methylation negative glioblastoma (搜索) patients, the target population for this clinical trial. Patients are currently being screened for enrollment.
Phase 2 Clinical Trial Details
The Phase 2 clinical trial is enrolling patients with aggressive, IDH wild-type, methylation negative glioblastomas. Radiation therapy is the standard of care for this patient population; however, outcome studies indicate that more than half of these patients live less than 12 months after diagnosis. The trial will randomize 40 patients into two 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 at the optimal dosage to reach the survival endpoint for comparison to historical controls. The company anticipates the trial will be completed within 18 to 24 months. The study (NCT06359379) can be found at www.clinicaltrials.gov.
Market Opportunity
Dr. Dritschilo noted that approximately 800,000 patients in the U.S. are treated with radiation therapy annually, with about 50% receiving radiation therapy with curative intent, according to the American Cancer Society and the American Society of Radiation Oncologists. The market opportunity for radiation sensitizers lies with the 400,000 patients treated to achieve cancer cures. The goal is that the results of this trial will be important to the cancer community as they look for effective radiation sensitizers to increase cancer cure rates, prolong patient survival, and improve the quality of life for patients suffering from glioblastoma (搜索).