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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

atic castrate resistant prostate cancer showing better than expected survival results, reductions 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 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 currently agreed on the design of two Phase 3 registration trials, via the Special Protocol Assessment (SPA) process, of OGX-011 in combination with second-line chemotherapy. One trial design investigates overall survival as the primary endpoint; the other trial design investigates pain palliation as the primary endpoint. OGX-011 has received Fast Track designation from the FDA for the treatment of progressive metastatic prostate cancer in combination with docetaxel.

OncoGenex holds an exclusive license for patents related to clusterin inhibition obtained from the University of British Columbia based on discoveries made by researchers at the Prostate Centre at Vancouver General Hospital. OGX-011 utilizes second-generation antisense technology, licensed from Isis Pharmaceuticals (NASDAQ: ISIS), to effectively target and inhibit production of clusterin protein in tumor cells. OncoGenex and Isis partnered in the successful discovery and initial development of OGX-011 and, in 2008, amended their agreement to provide OncoGenex with sole rights to OGX-011 and sole responsibility for development costs and partnering decisions, subject to financial obligations to Isis.

About the Special Protocol Assessment and Agreement Process

Under a Special Protocol Assessment (SPA), a company and the FDA can reach an agreement on the design and size of
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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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