Shuttle Pharma Advances Phase 2 Trial Of Ropidoxuridine For Glioblastoma Treatment

Shuttle Pharmaceuticals Holdings, Inc., a pharmaceutical company dedicated to improving radiation therapy outcomes for cancer patients, announced the enrolment and dosing of the first patient at the UVA Cancer Center in its Phase 2 clinical trial of Ropidoxuridine. This trial focuses on treating glioblastoma, one of the most aggressive and deadly brain tumors. The UVA Cancer Centre is one of six sites participating, alongside Miami Cancer Institute, which recently began patient dosing, Georgetown University Medical Centre, John Theurer Cancer Centre, and Allegheny Health Network (AHN) Cancer Institute.

The trial will initially enroll 40 patients randomised into two dosing groups (1,200 mg/day and 960 mg/day) to identify the optimal dose. Once determined, 14 patients will be added at the optimal dose, with survival as the primary endpoint compared to historical data. This study targets IDH wild-type, methylation-negative glioblastoma patients, a group with limited treatment options and poor survival rates, as over half live less than 12 months after diagnosis. Ropidoxuridine, Shuttle Pharma’s lead radiation sensitiser, aims to enhance the effectiveness of radiation therapy for these patients and has already received an Orphan Drug Designation from the FDA.

Shuttle Pharma’s Chairman and CEO, Anatoly Dritschilo, M.D., said, “I am pleased with the progress being made to advance our Phase 2 trial of ropidoxuridine for the treatment of patients with glioblastoma with the addition of the first patient being dosed at UVA Cancer Center." This is the second trial location announced to have treated patients.”

He also commented, “We have strategically aligned the trial with nationally recognised cancer centres across various regions to treat patients with IDH wild-type, methylation-negative glioblastoma, the target of the clinical trial. I look forward to the continued advancement of the trial as we leverage radiation sensitisers to increase cancer cure rates, prolong patient survival, and improve quality of life for patients suffering from glioblastoma.”

Radiation therapy is a crucial treatment for approximately 800,000 cancer patients in the U.S. each year, with half treated for curative purposes. The market for radiation sensitisers, like Ropidoxuridine, represents a significant opportunity, with an estimated 400,000 patients treated curatively annually, expected to grow by 22% over the next five years. This trial is essential in advancing therapies for glioblastoma patients and improving outcomes in radiation oncology.