Shuttle Pharma Advances Phase 2 Trial Of Ropidoxuridine For Glioblastoma

Shuttle Pharmaceuticals Holdings, Inc., a speciality pharmaceutical company focused on enhancing outcomes for cancer patients undergoing radiation therapy (RT), today announced that it has successfully dosed the first three patients in its Phase 2 clinical trial of Ropidoxuridine for glioblastoma treatment.

Ropidoxuridine (IPdR), Shuttle Pharma’s leading candidate, is a radiation sensitiser designed to improve RT effectiveness for glioblastoma, an aggressive brain cancer with limited treatment options and no cure. The FDA has granted Ropidoxuridine Orphan Drug Designation, which could provide market exclusivity upon approval.

The Phase 2 trial will focus on a particularly challenging group of patients with IDH wild-type, methylation-negative glioblastoma, a subtype where radiation is currently the only standard treatment and survival rates are typically less than a year. To determine the optimal dose, the study will enroll 40 patients to compare two dosing levels (1,200 mg/day and 960 mg/day). Following this, 14 additional patients will receive the optimal dose to achieve statistically significant survival outcomes against historical data. The trial is expected to be completed within 18-24 months.

“The initiation of patient dosing in our Phase 2 trial of Ropidoxuridine for the treatment of patients with glioblastoma is a significant milestone for both Shuttle Pharma and the thousands of patients with brain tumors who currently lack effective therapies. The results of this trial will be important as Shuttle Pharma looks to leverage radiation sensitizers to increase cancer cure rates, prolong patient survival and improve quality of life for patients suffering from glioblastoma,” commented Shuttle Pharma’s Chairman and CEO Anatoly Dritschilo, M.D.

Each year, approximately 800,000 cancer patients in the U.S. receive RT, half for curative purposes. The demand for radiation sensitizers like Ropidoxuridine is growing, with around 400,000 patients receiving curative RT, projected to increase by over 22% in the next five years, underscoring a substantial market opportunity for Shuttle Pharma’s innovative therapies.