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OncoGenex Pharmaceuticals, Inc. Provides Update on Clinical Development Program and Reports Financial Results for Fourth Quarter and Year End 2012
Date:3/7/2013

BOTHELL, Wash. and VANCOUVER, British Columbia, March 7, 2013 /PRNewswire/ -- OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today highlighted key clinical development activities for its two product candidates, custirsen and OGX-427, and announced its fourth quarter and year end 2012 financial results.

Custirsen Clinical Development Highlights

  • The Company announced completion of patient enrollment of more than 1,000 men in the primary registration Phase 3 SYNERGY study in the fourth quarter of 2012. The SYNERGY study is designed to evaluate a survival benefit for custirsen, in combination with first-line docetaxel chemotherapy, in men with metastatic castrate-resistant prostate cancer (CRPC).  The expected timing of results is based on a pre-specified number of death events that is projected to occur in the fourth quarter of 2013, with data results expected to be announced in the first half of 2014.
  • Patient enrollment began in the third quarter of 2012 in the Phase 3 AFFINITY study, evaluating a survival benefit for custirsen in combination with Jevtana® (cabazitaxel) as second-line chemotherapy. AFFINITY aims to enroll approximately 630 men with CRPC and is being conducted at sites throughout North America, Europe and Australia.
  • Patient enrollment began in the third quarter of 2012 in the Phase 3 ENSPIRIT trial, a randomized Phase 3 study in approximately 1,100 patients with advanced or metastatic non-small cell lung cancer (NSCLC). ENSPIRIT will evaluate the potential survival benefit of combining custirsen with docetaxel as second-line chemotherapy. Custirsen has also recently received Fast Track designation from the FDA for the second-line treatment of advanced NSCLC when combined with docetaxel
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