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news.OncoGenex Pharmaceuticals, a biopharmaceutical company, has announced positive survival results from a randomized Phase II clinical trial of OGX-011 in combination with docetaxel and prednisone compared to docetaxel and prednisone alone for first-line treatment of metastatic castrate resistant prostate cancer.
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The current 10.6 month median overall survival advantage observed in the OGX-011 arm represents an increase over the median survival observed in the control arm. Docetaxel was approved by the FDA based on a survival advantage of 2.4 months over mitoxantrone.
The study randomized 82 patients with metastatic or locally recurring prostate cancer refractory to hormone therapy. The median survival was 27.5 months for the patients in the OGX-011 arm and 16.9 months for those in the control arm. Results currently indicate that patients in the OGX-011 arm have a death rate approximately 40% lower than patients in the control arm.
The current results are based on study data with a median follow-up of approximately 30 months for both arms. Additional survival updates are needed before a mature median survival for the OGX-011 arm can be reported. Based on the current results, OncoGenex has calculated that the final median survival for patients in the OGX-011 arm cannot be lower than 22.7 months.