Shuttle Pharmaceuticals has reached 25% enrollment in the initial randomized portion of its Phase 2 clinical trial for Ropidoxuridine (IPdR), a radiation sensitizer for glioblastoma. The trial aims to determine the optimal dose of IPdR for patients with IDH wild-type, methylation negative glioblastoma, an aggressive form of brain cancer with limited treatment options. The company has received Orphan Drug Designation from the FDA for IPdR for this indication.
This progress is notable because it signals potential advancement in treating a particularly challenging cancer. Glioblastoma patients with this specific genetic profile currently rely primarily on radiation therapy, which often yields poor survival rates. A successful trial could significantly improve outcomes for these patients, potentially offering a new standard of care.
The Phase 2 trial is evaluating two dose levels of IPdR (1,200 mg/day and 960 mg/day) in 40 patients. After determining the optimal dose, an additional 14 patients will be enrolled to solidify the statistical significance of the survival endpoint compared to historical controls. The trial is being conducted across several prominent cancer centers in the United States.
Positive results from this trial could establish IPdR as a crucial component in glioblastoma treatment, particularly for this patient subgroup. This would represent a significant step forward in the fight against this aggressive cancer and solidify Shuttle Pharmaceuticals’ position in the oncology market. Further, the Orphan Drug Designation potentially grants the company market exclusivity, creating substantial commercial prospects if the drug receives FDA approval.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
