Dendreon Corporation Presents New Data Correlating Potency Of PROVENGE To Survival In Phase 3 Studies
SEATTLE and LOS ANGELES, Oct. 27 /PRNewswire-FirstCall/ -- Dendreon Corporation today announced data from an exploratory analysis of Phase 3 Studies (D9901 and D9902A) that showed a significant correlation between cumulative CD54 upregulation and survival for patients treated with Dendreon's investigational active cellular immunotherapy PROVENGE(R) (sipuleucel-T) in men with advanced androgen-independent (hormone refractory) prostate cancer.
CD54 upregulation is measured on antigen presenting cells (APCs) as part of the PROVENGE product release testing prior to administration to patients. The abstract entitled "CD54 Expression in Sipuleucel-T Correlates with Activation of APCs and Clinical Outcome" describes the characterization of PROVENGE and the development of CD54 as a surrogate measure of product potency. The poster was presented today at the International Society for Biological Therapy of Cancer (iSBTc) 21st Annual Meeting in Los Angeles.
"CD54 cell count and CD54 upregulation are important biologically-relevant measures used to assess the potency of PROVENGE prior to patient administration," said David Urdal, Ph.D., chief scientific officer of Dendreon Corporation. "The demonstration that there is a correlation between cumulative CD54 upregulation and clinical outcome suggests that our potency assay for PROVENGE measures an important and meaningful attribute of this product."
Cumulative CD54 upregulation was evaluated in PROVENGE-treated patients from the Phase 3 Studies D9901 and D9902A. Analyzing cumulative CD54 upregulation as a continuous variable yielded a significant correlation with survival (p-value = 0.011).
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 232,000 new cases of prostate cancer diagnosed each year. More than 30,000 men die each year of the disease.
PROVENGE (sipuleucel-T) is an investigational product that may represent the first in a new class of active cellular immunotherapies (ACIs) that are uniquely designed to stimulate a patient's own immune system. PROVENGE is in late-stage clinical development for the treatment of patients with early-stage and advanced prostate cancer. In clinical studies, patients typically received three infusions over a one-month period as a complete course of therapy.
Treatment with PROVENGE was generally well tolerated. In controlled clinical trials, the most common adverse reactions associated with PROVENGE were chills, fever, headache, fatigue, shortness of breath, vomiting and tremor. These events were primarily low grade events, with a short duration lasting 1 to 2 days following infusion.
Dendreon has submitted one of two portions of a rolling submission of a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for PROVENGE as an active cellular immunotherapy treatment for men with asymptomatic, metastatic, androgen-independent prostate cancer. The Company expects to submit the chemistry, manufacturing and controls (CMC) section of the BLA prior to the end of 2006. If approved, PROVENGE would become the first commercially available active cellular immunotherapy for advanced hormone-refractory prostate cancer.
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 a cell-mediated 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 headquarters in Seattle and is traded on The Nasdaq Stock Market(R) 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 a clinical trial for PROVENGE will not support an application 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 .Dendreon Corporation
CONTACT: Monique Greer, Sr. Director, Corporate Communications of DendreonCorporation, +1-206-829-1500
Web site: http://www.dendreon.com//