Dendreon Initiates Phase 2 Trial Of Provenge In Patients With Localized Prostate Cancer Prior To Surgery

Dendreon Corporation announced that the Company has initiated a Phase 2 trial of PROVENGE(R) (sipuleucel-T), Dendreon's investigational active cellular immunotherapy for the treatment of prostate cancer, in men with localized prostate cancer who are scheduled to undergo a radical prostatectomy. The single-center trial called NeoACT (NEOadjuvant Active Cellular immunoTherapy), or P07-1, which is being conducted at UCSF Helen Diller Family Comprehensive Cancer Center, has begun enrolling approximately 40 patients. NeoACT is the first of two new Phase 2 trials of PROVENGE being initiated this year.

Each patient will receive a complete course of active treatment over a one-month period beginning six to seven weeks prior to the patient's radical prostatectomy. The course of treatment will consist of three infusions of PROVENGE-two weeks apart. Multiple safety and efficacy endpoints will be evaluated including the immune response in the prostatectomy specimens and in the peripheral blood. Following radical prostatectomy, patients will be randomized to receive either a booster of PROVENGE or no booster. Patients interested in additional information about this trial may visit http://www.clinicaltrials.gov/ and use the search term "NeoACT."

"I am pleased to help lead the NeoACT clinical trial, given the therapeutic potential of immunotherapy for prostate cancer," stated Lawrence Fong, M.D., principal investigator of the NeoACT trial and associate professor of medicine at UCSF Helen Diller Family Comprehensive Cancer Center. "This study will provide a unique opportunity to examine the immune response to PROVENGE in actual prostate cancer tissue and to examine the correlation between immune responses in the tissue versus those in the circulating blood."

"Given the evidence of a survival benefit seen in our previous Phase 3 trial, D9901, in patients with advanced prostate cancer, we believe PROVENGE may also have applicability to men with earlier stages of the disease. This trial will help us better understand the mechanism of action and biology of PROVENGE, as well as evaluate the potential of PROVENGE in patients at high-risk for recurrence of their cancer following radical prostatectomy," stated Mark Frohlich, M.D., senior vice president, clinical affairs and chief medical officer of Dendreon. "We are highly focused on taking the steps necessary to get PROVENGE through the FDA approval process in order to get this important immunotherapy to prostate cancer patients with advanced disease who do not have any other reasonable options. We are on track to complete the interim analysis of our ongoing Phase 3 IMPACT trial during the latter half of this year."

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