SEATTLE, July 23 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN) today announced that it expects the Independent Data Monitoring Committee (IDMC) to review in October 2008 the interim analysis of overall survival relating to the Company's Phase 3 IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment, also known as D9902B) clinical trial of PROVENGE(R) (sipuleucel-T). PROVENGE is the Company's investigational active cellular immunotherapy for the treatment of advanced prostate cancer. Should the pre-specified criterion for statistical significance be achieved, Dendreon would anticipate amending its Biologics License Application (BLA) based on these interim results. The initial BLA filing was based primarily on an improvement in overall survival observed in Dendreon's Phase 3 trial D9901, a multi-center, randomized, double-blind, placebo-controlled trial.
Following the U.S. Food and Drug Administration (FDA) Advisory Committee vote that there was substantial evidence of efficacy of PROVENGE and that PROVENGE was reasonably safe, the FDA requested additional clinical data to support the proposed efficacy claim. The FDA has since indicated that either a positive interim or final analysis for overall survival from the IMPACT trial would be sufficient to address the request for additional information to support the proposed efficacy claim.
"We look forward to the interim results of the IMPACT trial this October. We are focused on providing the FDA with the additional data needed to obtain the regulatory approval of PROVENGE in an effort to rapidly bring this new therapy to the many prostate cancer patients who currently have few appealing treatment options. While the final analysis of the trial has a higher probability of success, the interim analysis provides us with the potential to accelerate our BLA amendment for PROVENGE," said Mitchell H. Gold, president and chief executive officer of Dendreon.
If the IDMC reports in October that the pre-specified criterion for statistical significance is not met, then the company anticipates continuing the trial with the expectation of reporting final results in the second half of 2009.
About IMPACT Study Design
The IMPACT trial is a multicenter, randomized, double-blind, placebo- controlled Phase 3 study, which enrolled just over 500 men with metastatic, androgen independent prostate cancer with a primary endpoint of overall survival. Dendreon is conducting the IMPACT trial under a Special Protocol Assessment (SPA) agreed upon with the FDA.
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 186,320 new cases expected to be diagnosed in 2008, and approximately 28,660 men expected to die this year from the disease. Currently there are limited treatment options for men with advanced, metastatic prostate cancer.
About 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 engage the patient's own immune system with the goal of eliciting a specific long-lasting response against cancer. Active cellular immunotherapy holds promise because it may provide patients with a meaningful clinical benefit, such as survival, combined with low toxicity.
Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development and commercialization of novel therapeutics. 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. Dendreon is also developing an orally-available small molecule called Trp-p8 that could be applicable to multiple types of cancer as well as benign prostatic hyperplasia. 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 http://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 http://www.sec.gov.
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