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OncoGenex Pharmaceuticals Completes Amendment to Phase 3 Special Protocol Assessment for Confirming Survival Benefit in Patients Receiving OGX-011 with First-Line Docetaxel for Metastatic Prostate Cancer
Date:6/24/2009

lumbia. 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. It is expected that approximately 80 sites, primarily from United States and Canada, will participate in this study.

The planned initiation of this Phase 3 trial evaluating survival is supported by Phase 2 data from patients receiving OGX-011 plus docetaxel as first-line chemotherapy presented at the 2009 Annual Meeting of the American Society of Clinical Oncology (ASCO) and reported on May 30th of this year. Analyses indicated the median overall survival in patients with advanced metastatic prostate cancer who were treated with OGX-011 plus docetaxel in a randomized Phase 2 trial was 23.8 months compared to 16.9 months for patients treated with docetaxel alone -- a 6.9 month observed survival advantage for the OGX-011 arm. Furthermore, the unadjusted hazard ratio (HR), a measure used to compare the death rates between treatment groups, was 0.61, representing a 39% lower rate of death for patients treated with OGX-011.

About OGX-011

OGX-011 is designed to inhibit the production of clusterin, a protein that is associated with cancer treatment resistance, and has completed Phase 2 clinical trials in prostate, lung and breast cancer.

Based on clinical results to date, OncoGenex intends to conduct two Phase 3 registration trials with OGX-011 in metastatic castrate resistant prostate cancer, subject to the receipt of additional funding. The U.S. Food & Drug Administration (FDA) has now agreed on the design of both Phase 3 registration trials, via the Special Protocol Assessment (SPA) process, of OGX-011 in combination with chemotherapy. One trial design investigates overall sur
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SOURCE OncoGenex Pharmaceuticals, Inc.
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