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OncoGenex Provides Update on Two-Year Survival Data from Ongoing Phase 1/2 Clinical Trial of OGX-011 in Non-Small Cell Lung Cancer
Date:2/4/2009

rage serum clusterin levels during treatment when compared to baseline levels (p (less than) 0.0001) and that achieving low average serum clusterin levels during treatment correlated with improved survival (p=0.012).

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 studies in prostate, lung and breast cancer. Recently, OncoGenex Pharmaceuticals announced that OGX-011 showed an overall survival advantage in a randomized, controlled Phase 2 Study 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. At the 2008 Annual Meeting of the American Society of Clinical Oncology meeting, OncoGenex reported OGX-011 Phase 2 data in second-line treatment of metastatic castrate resistant prostate cancer showing better than expected survival results in combination with chemotherapy, reduction in levels of clusterin, durable reductions in pain, and a decline in PSA, a protein that is often elevated in patients with prostate cancer.

Based on clinical results to date, OncoGenex intends to conduct Phase 3 registration studies with OGX-011 in metastatic castrate resistant prostate cancer, subject to the receipt of additional funding. The U.S. Food & Drug Administration (FDA) has agreed on the design of one Phase 3 registration trial in combination with second-line chemotherapy investigating overall survival as the primary endpoint via the Special Protocol Assessment (SPA) process. In addition, the FDA has confirmed that durable pain palliation is an acceptable primary endpoint for a registration trial in metastatic castrate resistant prostate cancer. OncoGenex intends to obtain an agreeme
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SOURCE OncoGenex Pharmaceuticals, Inc.
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4. OncoGenex increases economic interest in lead cancer drug OGX-011
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