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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

bling symptom of advanced prostate cancer, and pain control is a key measurement of clinical benefit."

The planned initiation of this Phase 3 trial evaluating pain palliation is supported by encouraging Phase 2 data from patients receiving OGX-011 plus docetaxel as second-line chemotherapy - additional data was presented at the 2009 Annual Meeting of the American Urological Association (AUA). Based on the 27 patients who had prostate cancer-related pain and received OGX-011 plus docetaxel as second-line chemotherapy, 12 patients or 44% of patients, experienced pain palliation for 3 months or longer. The majority of pain responses occurred within the first two cycles of OGX-011 plus docetaxel. These data compare favorably even when compared to pain responses observed after first-line chemotherapy. This is clinically relevant because patients receiving second-line treatment have more advanced disease and are thought to have more profound or resistant prostate cancer-related pain.

About OGX-011

OGX-011 is designed to inhibit the production of clusterin, a protein that is associated with cancer treatment resistance and is currently being evaluated in Phase 2 clinical trials in prostate, lung and breast cancer. OncoGenex Pharmaceuticals announced preliminary data on December 3, 2008 that OGX-011 showed an overall survival advantage in a randomized, controlled Phase 2 trial in first-line treatment of metastatic castrate resistant prostate cancer, in which the median survival for patients receiving OGX-011 in combination with docetaxel and prednisone was 27.5 months, compared to 16.9 months in patients receiving docetaxel and prednisone alone. Updated survival results will be presented at the 2009 Annual Meeting of the American Society of Clinical Oncology.

At the 2008 Annual Meeting of the American Society of Clinical Oncology, OncoGenex reported Phase 2 data with OGX-011 in combination with second-line treatment of metast
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SOURCE OncoGenex Pharmaceuticals, Inc.
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