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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

oints for which we have had success in our Phase 2 clinical trials. Based on the recent survival benefit of combining OGX-011 with first-line docetaxel chemotherapy, we have initiated discussions with FDA for evaluating the overall survival benefit in first-line CRPC, instead of second-line CRPC."

The Phase 3 trial evaluating durable pain palliation has been designed in collaboration with internationally recognized experts in the treatment of patients with CRPC (previously referred to as hormone-refractory prostate cancer) including Dr. Tomasz Beer at the University of Oregon and Dr. Sebastian Hotte at Juravinski Cancer Centre, in Hamilton, Ontario, Canada. This will be a randomized, controlled, international trial in approximately 300 men with metastatic CRPC who responded to first-line docetaxel therapy, but subsequently have progression of disease, including prostate cancer-related pain, and are able to receive docetaxel retreatment as second-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 trial will be to determine whether a greater proportion of patients in the arm treated with OGX-011 and docetaxel/prednisone experiences durable pain palliation as compared to patients in the arm treated with docetaxel/prednisone alone. It is expected that approximately 50 clinical sites in the United States and Canada will participate in this trial.

"Patients with pain due to metastatic prostate cancer generally require narcotic medications that are dosed to provide maximum pain relief; however, unacceptable side effects such as sedation and severe constipation remain dose-limiting. Because of this, patients frequently continue to suffer from pain despite 'optimally dosed' narcotics," said Cindy Jacobs, M.D., Ph.D., OncoGenex' Executive Vice-President and Chief Medical Officer. "Thus, pain is a common, often unremitting and disa
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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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