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OncoGenex Announces Completion of a Special Protocol Assessment (SPA) Amendment with the FDA Increasing Patient Eligibility for the Custirsen Phase III Prostate Cancer SATURN Clinical Trial
Date:9/19/2011

BOTHELL, Wash. and VANCOUVER, British Columbia, Sept. 19, 2011 /PRNewswire/ -- Today OncoGenex (NASDAQ: OGXI) announced that the company has successfully completed an amendment to the approved SPA with the U.S. Food and Drug Administration (FDA) to expand the inclusion criteria for the Prostate Cancer SATURN Clinical Trial - a Phase III study testing whether their experimental drug custirsen, also known as OGX-011/TV-1011, can improve quality of life by reducing cancer pain for more than 12 weeks in men with metastatic castrate-resistant prostate cancer (mCRPC). As part of the approved amendment to the protocol and the SPA, patients may now receive either docetaxel re-treatment or cabazitaxel as second-line taxane chemotherapy. The study design remains the same; all patients must have stable pain at study entry and will be randomized to receive custirsen or placebo in conjunction with taxane chemotherapy.

"Until recently, docetaxel was the only standard of care for chemotherapy treatment of mCRPC with a demonstrated survival benefit," said Dr. Tomasz Beer, the study's principal investigator in the United States.  "With the recent approval of cabazitaxel for mCRPC treatment after docetaxel, men have a new option that extends survival.  In an effort to improve the palliative benefits of this new treatment, we are evaluating custirsen with cabazitaxel for pain palliation. Pain palliation in patients treated with cabazitaxel was reported at 9.2% and pain is one of the most common and devastating consequences of very advanced prostate cancer."

Custirsen is an experimental drug that is designed to block the production of a protein that is associated with treatment resistance in many cancers. In Phase II trials, custirsen combined with docetaxel as either first-line or second-line chemotherapy showed a 6.9 month improvement in overall survival over doc
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SOURCE OncoGenex Pharmaceuticals
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