OncoGenex Receives Completed Special Protocol Assessment for Primary Registration Study of Lead Drug Candidate
News Jul 15, 2008
OncoGenex Technologies Inc. announced that the company has reached an agreement with the U.S. Food and Drug Administration (FDA) on the design of a Phase 3 registration trial of OGX-011, its lead product candidate targeting hormone refractory prostate cancer, via the Special Protocol Assessment (SPA) process.
In the letter responding to the OncoGenex submission, the FDA stated that they agreed with the design and planned analysis proposed by OncoGenex, and that the study design adequately addresses the objectives necessary to support a regulatory submission.
The Phase 3 trial has been designed in collaboration with internationally recognized experts in the treatment of patients with hormone-refractory prostate cancer (HRPC) including Dr. Celestia Higano at the University of Washington and Dr. Kim Chi at the University of British Columbia. This will be a randomized, controlled, international study in 765 men with metastatic HRPC who responded to first-line docetaxel therapy, but subsequently progressed and are in need of second-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. It is expected that approximately 80 sites in the United States and Canada will participate in this study.
"Patients who have progressed after receiving docetaxel as first-line chemotherapy have few options," said Cindy Jacobs, M.D., Ph.D., OncoGenex' Executive Vice-President and Chief Medical Officer.
"A recent survey of 130 oncologists practicing in Canada and the United States indicates that their primary option for patients who responded to first-line docetaxel is retreatment with docetaxel. This is not surprising since the only product shown to increase survival in patients with HRPC is docetaxel," Jacobs added.
Dr. Jacobs added, "Preliminary data from Phase 2 studies of OGX-011 in combination with docetaxel retreatment have indicated that OGX-011 may help restore tumor sensitivity to docetaxel and may improve overall survival for second-line therapy."