Strong interim Ph III Provenge data

USA-based Dendreon Corp has completed a planned interim analysis of the Phase III, randomized, double-blind, placebo-controlled IMPACT trial designed to assess the safety and efficacy of the investigational active cellular immunotherapy Provenge (sipuleucel-T) in men with metastatic androgen-independent prostate cancer.

While Dendreon remains blinded to the findings, the independent data monitoring committee reported a 20% reduction in the risk of death in the Provenge arm relative to placebo, and raised no safety concerns.

"The treatment effect we have observed in this interim analysis is consistent with that observed in the integrated analysis of our previous Phase III trials in this patient population when analyzed at a similar 24-month follow-up time," said Mitchell Gold, chief executive of Dendreon. "Given the delayed treatment effect we have seen in previous studies, we are pleased to see evidence suggesting a prolongation of survival in the Provenge arm at the time of the interim analysis, as well as a favorable safety profile," he added.