News about Provenge vaccine … getting closer:

Provenge prostate cancer vaccine linked to longer survival for asymptomatic hormone refractory stage — UCSF study. June 28, 2006.

Dendreon Announces Publication of Pivotal Phase 3 Study Highlighting Survival Benefit and Safety Profile of PROVENGE in Men with Advanced Prostate Cancer June 29, 2006
Dendreon Announces FDA Grants Fast Track Status for Provenge

Dendreon Announces FDA Grants Fast Track Status for Provenge

Earlier:
Dendreon’s Phase 3 Trial Shows Provenge Vaccine Extends Survival in Patients with Advanced Prostate Cancer Oct 28, 2004

Meanwhile in Europe:
Dendreon’s Second Randomized Phase 3 D9902A Trial of Provenge Extends Survival in Patients with Advanced Prostate Cancer

PARIS, FRANCE, October 31, 2005 – Dendreon Corporation (Nasdaq: DNDN) today announced that final results of its second Phase 3 study (D9902A) of PROVENGE® (sipuleucel-T), the Company’s investigational active cellular immunotherapy for the treatment of prostate cancer, were presented here today during a late-breaking clinical trials session at ECCO 13-the European Cancer Conference. Researchers concluded that these results are consistent with the results from the Company’s first Phase 3 study (D9901). The Company recently announced plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) to market PROVENGE based on discussions of these data with the FDA.

“The combined data from the trials of PROVENGE versus placebo demonstrate that active immunotherapy favorably impacts survival in men with asymptomatic, metastatic, androgen-independent prostate cancer,” reported Celestia S. Higano, M.D., director and associate professor of the Genitourinary Oncology Clinical Research Group at the University of Washington, Seattle, who presented the data. “Given the favorable side effect profile, PROVENGE may provide a useful alternative for men prior to initiating chemotherapy.”
Study Results
(full story…)