psycho-pharma schreef:
The heat is on!!!!!!!
Dendreon Completes Target Enrollment of 500 Patients in Phase 3 IMPACT Study of Provenge(R) For Advanced Prostate Cancer
--FDA Has Agreed That Positive Survival Data from IMPACT Study Would Support Licensure of PROVENGE--
--Interim Survival Results Expected in Second Half of 2008--
SEATTLE, WA, October 23, 2007 - Dendreon Corporation (Nasdaq: DNDN) today announced that the Company has completed enrollment of over 500 patients in the Phase 3 IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment, also known as D9902B) clinical trial of PROVENGE (sipuleucel-T), the Company's investigational active cellular immunotherapy for the treatment of advanced prostate cancer. The IMPACT study is a double-blind, randomized, placebo-controlled Phase 3 trial designed to measure overall survival in men with metastatic hormone-refractory prostate cancer receiving PROVENGE versus placebo.
Earlier this year, following a positive recommendation from an outside panel of experts, Dendreon received a complete response letter from the U.S. Food and Drug Administration (FDA) that asked for additional evidence that would support the efficacy of PROVENGE. Subsequently, Dendreon received confirmation that the FDA will accept either a positive interim or positive final analysis of overall survival from the IMPACT study to amend the Biologics License Application (BLA) and support the efficacy claim for PROVENGE.
"The completion of enrollment of over 500 patients into the IMPACT study is a major achievement for the organization, as the data from this trial may provide the FDA with the additional clinical data they need for the approval of PROVENGE," said Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. "Men with late stage prostate cancer currently have few appealing treatment options available to them. We believe PROVENGE has the potential to offer both oncologists and urologists a well tolerated treatment option for their patients that has the ability to extend survival."
The IMPACT study enrolled more than 500 patients at 70 centers in the United States and Canada. Patients with metastatic androgen-independent prostate cancer were eligible for the study. The primary endpoint of the study is overall survival (an event-driven analysis), and time to objective disease progression is a secondary endpoint. The company currently expects an interim analysis for overall survival to be performed in the second half of 2008.
"This study provides the medical community an important opportunity to better define the efficacy and safety profile of PROVENGE in men with metastatic androgen-independent prostate cancer," said Philip Kantoff, M.D., a principal investigator of IMPACT and chief clinical research officer and chief of the Division of Solid Tumor Oncology at the Dana-Farber Cancer Institute. "Considering the limited treatment options available to these critically ill patients, there is a real need for new, safe and effective treatments, particularly those providing a survival benefit."
P.