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PROVENGE Significantly Prolongs Survival in Men With Advanced Prostate Cancer in Pivotal Phase 3 IMPACT Study
Date:4/14/2009

- Study Meets Primary Endpoint Showing Statistically Significant Improvement in Overall Survival -

- First Active Immunotherapy for Cancer to Prolong Survival -

- Full Data to be Presented at Plenary Session at Upcoming AUA Annual Meeting -

- Company to Host a Conference Call Today at 9:00 AM ET -

SEATTLE, April 14 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN) announced today that the pivotal Phase 3 IMPACT study of PROVENGE(R) (sipuleucel-T) in men with advanced prostate cancer met its primary endpoint of improving overall survival compared to a placebo control. The magnitude of the survival difference observed in the intent to treat population resulted in the study successfully achieving the pre-specified level of statistical significance defined by the study's design. The safety profile of PROVENGE appeared to be consistent with prior trials.

The 512-patient, multi-center, randomized, double-blind, placebo-controlled IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) study enrolled men with metastatic androgen-independent prostate cancer was conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration (FDA).

PROVENGE is Dendreon's investigational product candidate for men with advanced prostate cancer and may represent the first in a new class of active cellular immunotherapies specifically designed to engage the patient's own immune system against cancer.

Detailed results from the IMPACT study will be presented during a plenary session at the American Urological Association's Annual Meeting in Chicago on Tues., Apr. 28 at 2:20 pm CT.

"Survival is the gold standard outcome for oncology clinical trials, and overall survival
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SOURCE Dendreon Corporation
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