BOTHELL, WA, and VANCOUVER, June 24 /PRNewswire-FirstCall/ - 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.
"We are now ready to proceed with two Phase 3 trial designs from the FDA via the SPA process, one in first-line and one in second-line treatment of advanced prostate cancer," said Scott Cormack, President and CEO of OncoGenex Pharmaceuticals. "The trial for first-line treatment evaluates overall survival benefit for OGX-011 while the trial for second-line treatment evaluates for a durable pain palliation benefit. Based on the robustness of the OGX-011 survival benefit observed in the randomized Phase 2 trial for first-line docetaxel treatment, we felt evaluating both of these patient populations, as well as both endpoints, in our Phase 3 trials better positions the availability of OGX-011 treatment to a larger number of men with prostate cancer."
The Phase 3 trial has been designed in collaboration with internationally recognized experts in the treatment of patients with castrate resistant prostate cancer (CRPC) including Dr. Celestia Higano at the
SOURCE OncoGenex Pharmaceuticals, Inc.
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