Shuttle Pharma Advances Phase 2 Trial For Promising Glioblastoma Treatment With Ropidoxuridine

Shuttle Pharmaceuticals Holdings, Inc., known as Shuttle Pharma, recently confirmed that it has secured agreements with all six clinical sites selected for the Phase 2 trial of its lead candidate, Ropidoxuridine (IPdR), aimed at treating glioblastoma patients who are undergoing radiation therapy. The latest agreements with Georgetown University Medical Center and UNC Medical Center join previously established partnerships with UVA Cancer Center, John Theurer Cancer Center at Hackensack University Medical Center, Allegheny Health Network (AHN) Cancer Institute, and Miami Cancer Institute.

Ropidoxuridine, designed as a radiation sensitizer, works to enhance the effectiveness of radiation therapy in treating brain tumors like glioblastoma — a typically fatal cancer for which no cure currently exists. The FDA has granted Orphan Drug Designation to Ropidoxuridine, a move that could allow for exclusive marketing rights if approved for glioblastoma treatment.

Shuttle Pharma’s CEO, Anatoly Dritschilo, M.D., said in a statement, “We have successfully engaged all six of the planned clinical trial site locations to administer the Phase 2 clinical trial of Ropidoxuridine. All six locations are nationally recognized cancer centers that are most likely to treat IDH wild-type, methylation negative glioblastoma patients, the target of the clinical trial. Patients are currently being evaluated for enrollment, having signed consents for treatment, and are now in the process of being screened.”

Dr. Dritschilo further continued, “An estimated 800,000 patients in the U.S. are treated with radiation therapy annually. According to the American Cancer Society and the American Society of Radiation Oncologists, about 50% of those patients receive radiation therapy with curative intent. 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.”

In this Phase 2 trial, 40 patients with aggressive, IDH wild-type, methylation-negative glioblastomas, for whom radiation remains the mainstay treatment, will be randomized into two dosage groups: 1,200 mg/day and 960 mg/day. The trial aims to identify the optimal dose before adding 14 more patients to continue dosing, with the ultimate goal of reaching survival benchmarks for comparison to past studies. With patients now being screened for enrollment, the company anticipates that the trial will span 18 to 24 months.