Healthcare Industry News: sipuleucel-T
News Release - February 14, 2008
Dendreon Presents Data Correlating the Cumulative Potency of PROVENGE(R) to Overall SurvivalNew Data Presented at American Society of Clinical Oncology's Genitourinary Symposium
SEATTLE and SAN FRANCISCO, Feb. 14 (HSMN NewsFeed) -- Researchers from Dendreon Corporation (Nasdaq: DNDN ) today presented data demonstrating the correlation of a measure of the cumulative potency of PROVENGE (sipuleucel-T), an investigational active cellular immunotherapy for hormone-refractory prostate cancer, with overall survival. This is the first time that an association between higher potency of an active immune therapy and increased patient survival has been reported. The correlation appeared to be independent of other important baseline prognostic factors.
The abstract (#21), "Cell Number and CD54 Expression in sipuleucel-T Correlate with Survival in Metastatic Androgen Independent Prostate Cancer," is being presented at the American Society of Clinical Oncology's 2008 Genitourinary Symposium in San Francisco.
In two Phase 3 trials, D9901 and D9902A, researchers evaluated cumulative product release parameters of PROVENGE, including CD54 upregulation (a measure of product potency defined as the increase of CD54 molecules expressed on Antigen Presenting Cells [APC] after incubation with the PROVENGE Antigen Delivery Cassette(TM)) and the number of total nucleated cells (TNCs) among patients treated with sipuleucel-T (n=146). CD54 is a costimulatory molecule which serves as a marker for APCs. Its expression is increased when APCs become activated and this upregulation of CD54 serves as a potency release assay for PROVENGE.
Results showed that PROVENGE patients experienced improved survival if they received more cells across the three doses of PROVENGE (higher cumulative TNC count (p=0.019)) or higher cumulative CD54 upregulation values (p=0.009). The effect on survival for TNCs appeared to reflect in part the patients' baseline prognostic factors. However, the CD54 upregulation ratio appeared to be an independent predictor of survival in patients who received PROVENGE, as the correlation remained strong even after adjusting for baseline prognostic factors (p=0.022).
"We have been able to show a correlation between patient survival and a measure of the cumulative potency of PROVENGE; such a correlation between product potency and clinical outcome has not been previously demonstrated with an active immunotherapy," said Mark Frohlich, MD, chief medical officer of Dendreon. "These data provide further evidence that sipuleucel-T is actively engaging the immune system in a clinically meaningful way that prolongs patient survival."
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.
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. In clinical studies, patients typically received three doses of PROVENGE 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 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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