OncoGenex Wins Approval to Initiate Phase III Cancer Registration Trial
Posted on: Tuesday, 15 July 2008, 09:01 CDT
OncoGenex Technologies has reached an agreement with the FDA on the design of a Phase III registration trial of OGX-011, its lead product candidate targeting hormone refractory prostate cancer, via the special protocol assessment 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 III trial 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 US and Canada will participate in this study.
Cindy Jacobs, OncoGenex's executive vice-president and chief medical officer, said: "Preliminary data from Phase II studies of OGX-011 in combination with docetaxel retreatment have indicated that OGX-011 may help restore tumor sensitivity to docetaxel and may improve overall survival for second-line therapy."
Source: Datamonitor
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