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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

    FDA confirms durable pain palliation as an acceptable primary endpoint
    for a regulatory submission in support of market approval

BOTHELL, WA, April 28 /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) on the design of a second Phase 3 registration trial of OGX-011, its lead product candidate targeting castrate resistant prostate cancer (CRPC), via the Special Protocol Assessment (SPA) process. The FDA has agreed that the design and planned analysis of our Phase 3 trial featuring durable pain palliation as the primary endpoint adequately addresses the objectives necessary to support a regulatory submission.

"We have now received confirmations on two separate Phase 3 trial designs from the FDA via the SPA process, each in second-line treatment of advanced prostate cancer," said Scott Cormack, President and CEO of OncoGenex Pharmaceuticals. "One trial design evaluates overall survival benefit while the second trial design evaluates reduction in pain as the primary endpoint. Having evaluated both of these endpoints in our Phase 2 trials, we are well positioned to re-evaluate each of these endpoints in larger Phase 3 registration trials."

"The FDA's acknowledgement of pain in addition to survival as key endpoints for market approval supports the basis of our OGX-011 development program for advanced prostate cancer," added Cormack. "Although we observed a positive effect on PSA in our Phase 2 trials of OGX-011, we recognize that PSA response has not been shown to correlate to a clinical benefit and therefore is not an acceptable endpoint for FDA approval. Our focus remains on survival and pain palliation, both endpoints that FDA has confirmed are appropriate for marketing approval, and both endp
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SOURCE OncoGenex Pharmaceuticals, Inc.
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