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OncoGenex Receives Confirmation from FDA on the Design of a Second Phase 3 Trial Evaluating OGX-011 for the Treatment of Advanced Prostate Cancer
Date:4/28/2009

oints for which we have had success in our Phase 2 clinical trials. Based on the recent survival benefit of combining OGX-011 with first-line docetaxel chemotherapy, we have initiated discussions with FDA for evaluating the overall survival benefit in first-line CRPC, instead of second-line CRPC."

The Phase 3 trial evaluating durable pain palliation has been designed in collaboration with internationally recognized experts in the treatment of patients with CRPC (previously referred to as hormone-refractory prostate cancer) including Dr. Tomasz Beer at the University of Oregon and Dr. Sebastian Hotte at Juravinski Cancer Centre, in Hamilton, Ontario, Canada. This will be a randomized, controlled, international trial in approximately 300 men with metastatic CRPC who responded to first-line docetaxel therapy, but subsequently have progression of disease, including prostate cancer-related pain, and are able to receive docetaxel retreatment as 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 trial will be to determine whether a greater proportion of patients in the arm treated with OGX-011 and docetaxel/prednisone experiences durable pain palliation as compared to patients in the arm treated with docetaxel/prednisone alone. It is expected that approximately 50 clinical sites in the United States and Canada will participate in this trial.

"Patients with pain due to metastatic prostate cancer generally require narcotic medications that are dosed to provide maximum pain relief; however, unacceptable side effects such as sedation and severe constipation remain dose-limiting. Because of this, patients frequently continue to suffer from pain despite 'optimally dosed' narcotics," said Cindy Jacobs, M.D., Ph.D., OncoGenex' Executive Vice-President and Chief Medical Officer. "Thus, pain is a common, often unremitting and disa
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SOURCE OncoGenex Pharmaceuticals, Inc.
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