Dendreon Corporation announced the presentation of safety data from the integrated analysis of four randomized Provenge (sipuleucel-T) clinical trials of an autologous cellular immunotherapy in prostate cancer at the 105th Annual Scientific Meeting of the American Urological Association (AUA) in San Francisco.

"The approval of Provenge provides us with an important new, front-line option for men with asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer," said Simon Hall, director of the Barbara and Maurice Deane Prostate Health and Research Center at Mount Sinai Medical Center.

The analysis includes data from four randomized trials in patients with either metastatic castrate resistant prostate cancer (Studies D9901, D9902A, IMPACT) or androgen dependent prostate cancer (Study P-11) that were integrated to examine the safety profile of Provenge across the four studies. The safety evaluation of Provenge was based on 601 prostate cancer patients in four randomized clinical trials who underwent at least one leukapheresis procedure. The abstract presented was a poster presentation by Dr Hall, titled "Integrated safety results from four randomized, double-blind, placebo-controlled studies of sipuleucel-T (abstract #1000875)."

Provenge is the first autologous cellular immunotherapy to be approved by the US Food and Drug Administration for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.

Provenge is classified by the US FDA as an autologous cellular immunotherapy. It is designed to be an active cellular immunotherapy.

Dendreon Corporation is a biotechnology company targeting cancer and transforming lives through the discovery, development, commercialization and manufacturing of novel therapeutics.