SEATTLE, Feb. 27, 2008 - Dendreon Corporation (Nasdaq: DNDN) announced the publication of a manuscript titled, "CD54 is a surrogate marker of antigen presenting cell activation" in Cancer Immunology, Immunotherapy.
The manuscript describes and supports the use of CD54 as a surrogate marker of antigen presenting cell activation (APC) activation and validates its utility as a potency measure of PROVENGE® (sipuleucel-T). In particular, it describes how Dendreon researchers used CD54 and the upregulation of its expression on antigen presenting cells (APC) as a means by which human APC activation could be assessed and most importantly, how such measurements could be used to determine the potency of PROVENGE before its administration to patients with prostate cancer. The assessment of product potency is a key release measure required by the U.S. Food and Drug Administration (FDA).
The upregulation of CD54 has been used as part of the potency assay for PROVENGE since the initiation of the PROVENGE clinical development program. Data correlating CD54 upregulation to overall survival in patients from two Phase 3 trials, D9901 and D9902A have been presented at recent scientific meetings and at the FDA Cell Tissue and Gene Therapy Advisory Committee Meeting on March 29, 2007.
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 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.
Jennifer Cook Williams