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OncoGenex Pharmaceuticals Announces OGX-011 Treatment Provides Survival Benefit in Randomized Phase 2 Trial in Advanced Metastatic Prostate Cancer

ith OGX-011 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 OGX-011 and docetaxel when administered in combination, measuring the effect of OGX-011 plus docetaxel or docetaxel alone on serum clusterin levels and describing time to progression and overall patient survival. Baseline characteristics were well balanced between the treatment arms. In addition to the survival results presented and based on a median follow-up of 32 months, data were presented as summarized below.

    -   The OGX-011 plus docetaxel arm met the primary endpoint of the trial
        given that 58% of patients treated with OGX-011 plus docetaxel
        achieved confirmed PSA declines of 50% or greater.

    -   The median number of treatment cycles administered was 9 cycles in
        the OGX-011 plus docetaxel arm compared to 7 cycles in the docetaxel
        arm. The majority of patients either completed all 10 cycles of trial
        treatment (34 patients) or discontinued trial treatment based on
        disease progression (23 patients) or adverse events (14 patients).

    -   Fewer than half as many patients in the OGX-011 plus docetaxel arm
        (7 patients) discontinued trial treatment early for PSA progression
        and/or objective disease progression compared to the docetaxel arm
        (16 patients). Of the 9 patients in the OGX-011 arm that discontinued
        for adverse events, 7 of these patients experienced adverse events
        during the 8th and 9th treatment cycles.

    -   Evidence of a pharmacodynamic effect in the OGX-011 plus docetaxel
        arm was observed with statistically significant declines in serum
        clusterin levels within the first cycle of trial treatment when
        compared to levels in the docetaxel arm. OGX-011 has been shown to
SOURCE OncoGenex Pharmaceuticals, Inc.
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