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Data Presented at AUA Demonstrate PROVENGE Significantly Prolongs Survival for Men With Advanced Prostate Cancer in Pivotal Phase 3 IMPACT Study
Date:4/28/2009

ortantly, the men with advanced prostate cancer who have participated in our clinical trials over the last decade and whose courage and contribution have significantly advanced the understanding and treatment of prostate cancer and the potential role of cancer immunotherapies," added Dr. Gold.

Prostate cancer is the most common non-skin cancer in the United States and the third most common cancer worldwide. More than one million men in the United States have prostate cancer, with an estimated 186,320 new cases and approximately 28,660 men expected to die from the disease in 2008. Currently there are limited treatment options for men with advanced, metastatic prostate cancer.

IMPACT Study Detail and Additional Results

IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) was a 512-patient, multi-center, randomized, double-blind, placebo-controlled study evaluating men with asymptomatic or minimally symptomatic, metastatic, androgen-independent prostate cancer, and the primary endpoint was overall survival.

In addition to the results described above, the treatment effect was consistent across multiple patient subsets and remained consistent using the log rank test and an unadjusted Cox model (HR=0.766, p-value=0.023), and after adjustment for docetaxel use following investigational therapy (HR=0.763; p-value=0.036). Prostate cancer-specific survival also favored the PROVENGE arm (HR=0.772; p-value=0.036). Consistent with other trials in this patient population, PROVENGE did not significantly delay time to progression. The adverse events seen more commonly in PROVENGE-treated patients were chills, fever, and headache. These events were primarily low grade with a short duration of 1-2 days following infusion.

About PROVENGE

PROVENGE(R) (sipuleucel-T), an investigational product in development for men with androgen-indep
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SOURCE Dendreon Corporation
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