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OncoGenex Pharmaceuticals Announces OGX-011 Treatment Provides Survival Benefit in Randomized Phase 2 Trial in Advanced Metastatic Prostate Cancer
Date:5/30/2009

primarily target tissue clusterin levels with serum levels as an indicator of biological effect. - Higher incidence of stable disease (20 patients in OGX-011 plus docetaxel arm versus 12 patients in docetaxel arm) with lower incidence of disease progression as best response (1 patient in OGX- 011 plus docetaxel arm versus 4 patients in docetaxel arm) occurred in patients with measurable disease who were treated with OGX-011 plus docetaxel compared to the docetaxel arm; although, the incidence of overall response was comparable.

OGX-011 treatment was well tolerated in combination with docetaxel. There was an increase in incidence of mild fever, chills and creatinine levels (a laboratory measure for reduced kidney function) and a moderate to significant decrease in circulating lymphocytes in the blood (another laboratory measure) without any increase in infection rate compared to the docetaxel arm. The investigators concluded that the combination was well tolerated.

Brent Blumenstein, an independent statistician who conducted additional sensitivity analyses of the results, found that the survival benefit in the OGX-011 arm to be robust and not dependent on clinical trial sites or baseline characteristics of the patients.

"There is a clear separation of the survival curves," said Blumenstein. "A hazard ratio of 0.61 indicates a distinct difference in survival rates and fully justifies further Phase 3 trials. It is rare for a new intervention at this stage of development to have such strong data from a randomized clinical trial."

Cormack added, "These data clearly justify advancing to Phase 3 development, and we expect these data will be key in our partnering discussions for future clinical development and potential commercialization."

The trial was supported by funding from the Canadian Cancer Society and was conducted by the NCIC Clinical Trials
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SOURCE OncoGenex Pharmaceuticals, Inc.
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