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OncoGenex Pharmaceuticals, Inc. - Journal of Clinical Oncology Publishes Data from Randomized Phase 2 Custirsen Trial
Date:9/22/2010

terin levels occurred within the first cycle of custirsen treatment when compared to levels in the docetaxel arm, indicating on-target biological activity of custirsen; - Measurable stable disease was higher (77% in custirsen plus docetaxel arm versus 50% in docetaxel arm) and disease progression, without any response to therapy, was lower (4% in custirsen plus docetaxel arm versus 17% in docetaxel arm). The incidence of overall objective response was comparable; - Because the primary endpoint of the study was achieved and survival benefit was observed, custirsen warrants further study in Phase 3 trials.

"Despite the number of new treatment options for patients with advanced prostate cancer, many patients will eventually experience disease progression. We believe custirsen has the potential to reduce treatment resistance thereby increasing the efficacy of various therapeutic agents such as docetaxel, and are hopeful this will be confirmed through the Phase 3 development program," said Scott Cormack, president and CEO of OncoGenex.

In 2009, Teva Pharmaceutical Industries Ltd. and OncoGenex Pharmaceuticals, Inc. entered into a global license and collaboration agreement to develop and commercialize custirsen.

Phase 2 Study Design

In this Phase 2 study, 82 patients were randomized to one of two treatment arms to receive either 640 mg per week of custirsen by intravenous infusion in combination with docetaxel/prednisone or docetaxel/prednisone alone. Patients in both treatment arms received therapy until disease progression, toxicity or completion of ten 3-week cycles of therapy. The primary endpoint of the trial was to achieve a 50% reduction in PSA from baseline in over 50% of the patients treated with custirsen plus docetaxel. Secondary endpoints included determining objective response and duration of response in those patients with measurable disease at baseline, determining the tolerability and toxicity of weekly custirsen in combinati
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SOURCE OncoGenex Pharmaceuticals, Inc.
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