OncoGenex Pharmaceuticals (OGXI) Completes Amendment to Phase 3 for Confirming Survival Benefit in Patients with First-Line Docetaxel for Metastatic Prostate Cancer
More News related to OGXI
- OncoGenex Reports Third Quarter 2009 Financial Results
- OncoGenex Pharmaceuticals to Release Third Quarter 2009 Financial Results
- OncoGenex Pharmaceuticals CEO Named Canada's Pacific Ernst & Young's Entrepreneur Of The Year(R) in the Health Sciences Category
- FDA Grants Additional Fast Track Designation for OGX-011 in Combination with First Line Chemotherapy
- RBC Capital Initiates Coverage on OncoGenex Pharmaceuticals (OGXI) with an Outperform
OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced today that the company has reached an agreement with the U.S. Food and Drug Administration (FDA) via the special protocol assessment process (SPA) on an amendment to the design of a Phase 3 registration trial of OGX-011, its lead product candidate targeting castrate resistant prostate cancer (CRPC). The FDA has agreed on modifications to the study population of a previously reviewed Phase 3 trial featuring survival as the primary endpoint. The study population has been modified to evaluate patients receiving first-line chemotherapy, rather than those receiving second-line chemotherapy. FDA agreed that the amended protocol adequately addresses the objectives necessary to support a regulatory submission.
Related Categories
Corporate NewsFDA
Stocks Mentioned
+1.00Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!
