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OncoGenex Pharmaceuticals, Inc. Provides Clinical Development Program Overview and Reports Financial Results for First Quarter 2013
Date:5/2/2013

l of 2013 and patient enrollment of approximately 155 patients is expected to begin in mid-2013. 
  • The Rainier™ Trial is an investigator-sponsored, randomized, placebo-controlled Phase 2 trial evaluating OGX-427 in combination with ABRAXANE® (paclitaxel protein-bound particles for injectable suspension)(albumin-bound) and gemcitabine in approximately 130 patients with previously untreated metastatic pancreatic cancer. Plans for Rainier were announced in May of 2013 and patient enrollment is expected to begin in mid-2013.
  • The Pacific™ Trial is an investigator-sponsored, randomized Phase 2 trial evaluating OGX-427 in approximately 80 men with metastatic castrate-resistant prostate cancer (CRPC) who are experiencing rising prostate-specific antigen (PSA) while receiving Zytiga® (abiraterone acetate). The trial was initiated in December of 2012, and is currently enrolling at sites in the United States and Canada.
  • Custirsen Program Update

  • The primary registration Phase 3 SYNERGY trial, designed to evaluate a survival benefit for custirsen in combination with first-line docetaxel chemotherapy in men with metastatic CRPC, completed enrollment in 2012. The SYNERGY trial is continuing as planned per the recommendation of an independent Data Monitoring Committee (DMC), who have completed the second and last futility analyses per protocol. The planned efficacy interim analysis has not yet occurred. The expected timing of final 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 continues in the additional Phase 3 custirsen trials, AFFINITY and ENSPIRIT. The AFFINITY trial will evaluate the potential survival benefit of custirsen in combination with Jevtana® (cabazitaxel) as second-line chemo
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