FDA and EMA approve Phase 3 trial of masitinib in MCRPC, with positive implications for AB Science.

AB Science received FDA and EMA approval for a Phase 3 trial of masitinib in metastatic castrate-resistant prostate cancer. The trial will enroll 600 patients with less advanced disease and focus on efficacy and safety of docetaxel plus masitinib versus docetaxel plus placebo. Primary endpoint is radiographic progression free survival. AB Science also filed a patent application for treating mCRPC with masitinib, which was granted by the European Patent Office until 2042. This patent covers treatment of mCRPC in patients with low metastatic involvement, matching the patient population in the Phase 3 study.

Read more at Nasdaq.: FDA And EMA Approve AB Science’s Phase 3 Masitinib Trial In MCRPC