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Dendreon Announces Data on PROVENGE Potency and Long-Term Immune Responses in Androgen-Dependent Prostate Cancer
Date:4/19/2009

ed through 13 weeks after the booster infusion (p < 0.001). The PROVENGE booster infusions occurred from 0.2 to 5.5 years (median 1.1 years) after the week four dose.

Data is being presented in a session titled, "Cancer Vaccines: Human Studies" in a presentation titled, "Antigen presenting cell activation in sipuleucel-T and long-term immune responses in prostate cancer trial" today at 8:00 AM MDT at the 100th Annual Meeting of the Association for Cancer Research in Denver, Colorado.

"We are encouraged to see that CD54 upregulation in APCs is maintained after boosting in men with androgen-dependent prostate cancer," said David Urdal, chief scientific officer of Dendreon. "This pattern of CD54 upregulation suggests that the first dose 'primes' the immune system for subsequent 'memory' responses and is consistent with that observed in our studies of men with androgen-independent disease where the cumulative CD54 upregulation dose correlated with survival. We also are encouraged by these data which suggest that the immune response generated by PROVENGE is durable for a year or more after initial treatment and that it can be maintained following boosting."

Study Design

The study, known as PROTECT (PROvenge Treatment and Early Cancer Treatment) or P-11, is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety and biologic activity of PROVENGE in men with non-metastatic androgen-dependent prostate cancer who have had a prostate-specific antigen (PSA) recurrence following surgical removal of the prostate. A total of 176 patients at 19 sites in the United States were randomized two to one to receive PROVENGE or placebo following a three-month course of hormonal therapy. Patients were then followed with serial PSA measurements to evaluate the impact of PROVENGE on PSA and PSADT (PSA doubling time). At the time of biochemical progression, defined as a PSA of 3 ng/mL or
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SOURCE Dendreon Corporation
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