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OncoGenex Reports Financial Results for Fourth Quarter and Fiscal Year 2008 and Provides Outlook for 2009
Date:3/11/2009

hs (all durations were 12 weeks or greater). - Potential Correlation of Clusterin Levels to Survival - preliminary analyses have shown that treatment with OGX-011 in combination with chemotherapy significantly lowers serum clusterin levels and that low average serum clusterin levels during OGX-011 treatment correlate to longer survival. FDA Highlights "With a robust clinical and non-clinical data package supporting OGX-011, we are working closely with the FDA to develop Phase 3 study designs and protocols defining a registration path for product approval," added Cormack. - An agreement with the FDA was reached on the design of a Phase 3 registration trial featuring overall survival as the primary endpoint for OGX-011 in combination with docetaxel as second-line chemotherapy in men with CRPC, via the SPA process. In a letter from the FDA responding to the OncoGenex submission, the FDA stated that they agreed with the design and planned analyses proposed by OncoGenex, and that the study design adequately addressed the objectives necessary to support a regulatory submission. - Fast Track designation was received from the FDA for development of OGX-011 in combination with docetaxel for progressive metastatic prostate cancer. Fast Track designation was granted on the basis that OGX-011 may provide a significant improvement in the safety or effectiveness of the treatment for a serious or life threatening disease. - In a meeting with OncoGenex, the FDA agreed that "durable pain palliation is an acceptable and desirable study endpoint" to support a product marketing approval for OGX-011 in combination with docetaxel as second-line chemotherapy in men with CRPC. OncoGenex has revised the protocol based on the FDA's recommendations and has
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SOURCE OncoGenex Pharmaceuticals, Inc.
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Related biology technology :

1. OncoGenex reports lead drug candidate OGX-011 achieved primary endpoint in Phase 2 Trial with second-line chemotherapy for prostate cancer
2. Sonus Pharmaceuticals and OncoGenex Technologies to Merge
3. OncoGenex to present at the Needham & Company 7th Annual Biotechnology & Medical Technology Conference
4. OncoGenex increases economic interest in lead cancer drug OGX-011
5. OncoGenex receives completed Special Protocol Assessment for primary registration study of lead drug candidate OGX-011
6. Sonus Pharmaceuticals and OncoGenex Technologies complete business combination; OncoGenex Pharmaceuticals to commence trading on NASDAQ Capital Market today
7. FDA Grants Fast Track Designation for OncoGenex Pharmaceuticals Lead Product Candidate OGX-011
8. OncoGenex Pharmaceuticals announces out-license of TOCOSOL Paclitaxel to Eagle Pharmaceuticals
9. OncoGenex To Present At The BioContact Quebec 2008 Annual Conference
10. OncoGenex Achieves Key Regulatory Milestone for Lead Product Candidate, OGX-011
11. OncoGenex Pharmaceuticals to Release Third Quarter Financial Results
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