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OncoGenex Pharmaceuticals, Inc. Provides Clinical Development Program Overview and Reports Financial Results for Second Quarter 2013
Date:8/8/2013

any-sponsored, randomized, placebo-controlled Phase 2 trial of apatorsen in combination with first-line gemcitabine and cisplatin in patients with metastatic bladder cancer. Approximately 180 patients have been randomized into Borealis-1 at 55 clinical sites throughout North America and Europe. The primary endpoint of the trial is overall survival and data are expected to be available in the the second-half of 2014.
  • In August 2013, the Company announced initiation of patient enrollment in the Spruce™ clinical trial. Spruce is an investigator-sponsored, randomized, double-blind, placebo-controlled Phase 2 trial evaluating apatorsen in patients with previously untreated advanced non-squamous NSCLC.
  • In addition to Borealis-1 and Spruce, as part of the ORCA™ (Ongoing Studies Evaluating Treatment Resistance in CAncer) program, apatorsen is currently being evaluated in the following investigator-sponsored, randomized Phase 2 trials across four tumor types. Recent updates to additional ORCA trials are as follows:
  • The Borealis-2™ Trial was initiated in April 2013 and is currently enrolling patients. This investigator-sponsored, randomized, open-label Phase 2 trial is evaluating apatorsen in combination with docetaxel in patients with advanced or metastatic bladder cancer who have disease progression following first-line platinum-based chemotherapy. Borealis-2 aims to enroll approximately 200 patients.
  • The Cedar™ Trial is an investigator-sponsored, randomized, open-label Phase 2 trial evaluating apatorsen in previously untreated patients with advanced squamous cell lung cancer. Plans to initiate Cedar were announced in May 2013. The trial aims to enroll approximately 140 patients and is being conducted in the UK.
  • The Rainier™ Trial is an investigator-sponsored, randomized, placebo-controlled Phase 2 trial evaluating apatorsen in combination wi
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