| HOME >> BIOLOGY >> TECHNOLOGY |
VANCOUVER, July 14 /PRNewswire/ - OncoGenex Technologies Inc. announced today that the company has reached an agreement with the U.S. Food and Drug Administration (FDA) on the design of a Phase 3 registration trial of OGX-011, its lead product candidate targeting hormone refractory prostate cancer, via the Special Protocol Assessment (SPA) process. In the letter responding to the OncoGenex submission, the FDA stated that they agreed with the design and planned analysis proposed by OncoGenex, and that the study design adequately addresses the objectives necessary to support a regulatory submission.
The Phase 3 trial has been designed in collaboration with internationally recognized experts in the treatment of patients with hormone-refractory prostate cancer (HRPC) including Dr. Celestia Higano at the University of Washington and Dr. Kim Chi at the University of British Columbia. This will be a randomized, controlled, international study in 765 men with metastatic HRPC who responded to first-line docetaxel therapy, but subsequently progressed and are in need of 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 study will be overall survival. It is expected that approximately 80 sites in the United States and Canada will participate in this study.
"Patients who have progressed after receiving docetaxel as first-line chemotherapy have few options," said Cindy Jacobs, M.D., Ph.D., OncoGenex' Executive Vice-President and Chief Medical Officer. "A recent survey of 130 oncologists practicing in Canada and the United States indicates that their primary option for patients who responded to first-line docetaxel is retreatment with docetaxel. This is not surprising since the only product shown to increase survival in patients with HRPC is docetaxel."
Dr. Jacobs added, "Preliminary data from Phase 2 studies of OGX-011 in
com
'/>"/>
| SOURCE OncoGenex Technologies Inc. Copyright©2008 PR Newswire. All rights reserved |
Related biology technology :
1. OncoGenex increases economic interest in lead cancer drug OGX-011
2. OncoGenex to present at the Needham & Company 7th Annual Biotechnology & Medical Technology Conference
3. Sonus Pharmaceuticals and OncoGenex Technologies to Merge
4. OncoGenex reports lead drug candidate OGX-011 achieved primary endpoint in Phase 2 Trial with second-line chemotherapy for prostate cancer
5. CV Therapeutics Receives European Marketing Authorization for Ranolazine for the Treatment of Patients With Chronic Angina
6. Epeius Biotechnologies Tumor-Targeted Rexin-G Receives FDA Orphan Drug Designation for the Treatment of Osteosarcoma
7. Edison Pharmaceuticals Receives Commendation From the City of San Jose
8. GeneraMedix Inc. Receives Approval for Epoprostenol for Injection 1.5 mg
9. Microfluidic Systems Receives Continued Funding From the Department of Homeland Security (DHS) Toward the Commercial Production of Autonomous Airborne Pathogen Detection Systems
10. Par Pharmaceutical Receives Final Approval to Market Generic Marinol(R) CIII (Dronabinol) Capsules
11. Indevus Receives Approvable Letter from FDA for NEBIDO(R)
| Copyright © 2003-2012 Bio-Medicine. All rights reserved. ABOUT | CONTACT US | DISCLAIMER | PRIVACY POLICY | TERMS AND CONDITIONS |  |