OncoGenex Completes Amendment To Phase-III Special Protocol Assessment For OGX-011

OncoGenex has signed an agreement with FDA via the special protocol assessment process (SPA), on an amendment to the design of a phase-III registration trial of OGX-011. It is the company’s product candidate targeting castrate resistant prostate cancer (CRPC).

FDA has agreed on modifications to the study population of a previously reviewed phase-III trial featuring survival as the primary endpoint. The study population has been modified to evaluate patients receiving first-line chemotherapy, rather than those receiving second-line chemotherapy. FDA agreed that the amended protocol adequately addresses the objectives necessary to support a regulatory submission.

The revised trial will be a randomized, controlled, international study in 800 men with metastatic CRPC, who are in need of first-line chemotherapy. Patients will be randomized to receive treatment with either OGX-011 and docetaxel/prednisone or docetaxel/prednisone alone. The primary endpoint of the study will be overall survival, the company said.

Scott Cormack, President and CEO of OncoGenex, said: We are now ready to proceed with two Phase 3 trial designs from the FDA via the SPA process, one in first-line and one in second-line treatment of advanced prostate cancer.