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Dendreon Expects Interim Data Analysis for Phase 3 PROVENGE IMPACT Trial in October
Date:7/23/2008

SEATTLE, July 23 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN) today announced that it expects the Independent Data Monitoring Committee (IDMC) to review in October 2008 the interim analysis of overall survival relating to the Company's Phase 3 IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment, also known as D9902B) clinical trial of PROVENGE(R) (sipuleucel-T). PROVENGE is the Company's investigational active cellular immunotherapy for the treatment of advanced prostate cancer. Should the pre-specified criterion for statistical significance be achieved, Dendreon would anticipate amending its Biologics License Application (BLA) based on these interim results. The initial BLA filing was based primarily on an improvement in overall survival observed in Dendreon's Phase 3 trial D9901, a multi-center, randomized, double-blind, placebo-controlled trial.

Following the U.S. Food and Drug Administration (FDA) Advisory Committee vote that there was substantial evidence of efficacy of PROVENGE and that PROVENGE was reasonably safe, the FDA requested additional clinical data to support the proposed efficacy claim. The FDA has since indicated that either a positive interim or final analysis for overall survival from the IMPACT trial would be sufficient to address the request for additional information to support the proposed efficacy claim.

"We look forward to the interim results of the IMPACT trial this October. We are focused on providing the FDA with the additional data needed to obtain the regulatory approval of PROVENGE in an effort to rapidly bring this new therapy to the many prostate cancer patients who currently have few appealing treatment options. While the final analysis of the trial has a higher pro
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SOURCE Dendreon Corporation
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