Dendreon Completes Target Enrollment of 500 Patients in Phase 3 IMPACT Study of Provenge 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, Oct. 23 -- Dendreon Corporation 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."
About Prostate Cancer
Prostate cancer is the most common non-skin cancer in the United States and the third most common cancer worldwide. More than one million men in the United States have prostate cancer, with an estimated 218,890 new cases expected to be diagnosed in 2007, and more than 27,000 men expected to die this year from the disease. Currently, there are limited treatment options for men with advanced, metastatic prostate cancer.
Active Cellular Immunotherapy with PROVENGE
PROVENGE may represent the first product in a new class of active cellular immunotherapies (ACIs) that are uniquely designed to use live human cells to re-engage the patient's own immune system with the goal of turning it "back on" to elicit a specific long-lasting response against cancer. In clinical studies, patients typically received three infusions over a one-month period as a complete course of therapy.
Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development and commercialization of novel therapeutics that harness the immune system to fight cancer. The Company applies its expertise in antigen identification, engineering and cell processing to produce active cellular immunotherapy product candidates designed to stimulate an immune response. Active cellular immunotherapy holds promise because it may provide patients with a meaningful clinical benefit, such as survival, combined with low toxicity. The Company has its headquarters in Seattle, Washington and is traded on the Nasdaq Global Market under the symbol DNDN. For more information about the Company and its programs, visit www.dendreon.com.
Except for historical information contained herein, this news release contains forward-looking statements that are subject to risks and uncertainties surrounding the efficacy of PROVENGE to treat men suffering from prostate cancer, risks and uncertainties surrounding the presentation of data to the FDA and approval of product applications by the FDA and risks and uncertainties inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics. Factors that may cause such differences include risks related to our limited operating history, risks associated with completing our clinical trials, the risk that the safety and/or efficacy results of existing clinical trials or from additional clinical trials for PROVENGE will not support approval for a biologics license, the risk that the FDA may interpret data differently than we do or require more data or a more rigorous analysis of data than expected, the risk that the FDA will not approve a product for which a biologics license has been applied, the risk that the results of a clinical trial for PROVENGE or other product may not be indicative of results obtained in a later clinical trial, risks that we may lack the financial resources and access to capital to fund required clinical trials or commercialization of PROVENGE, our dependence on the efforts of third parties, and our dependence on intellectual property. Further information on the factors and risks that could affect Dendreon's business, financial condition and results of operations are contained in Dendreon's public disclosure filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov.