Dendreon Completes Patient Enrollment in First Phase III Clinical Trial of Provenge for Prostate Cancer; Clinical Results Expected by Year End.Business Editors & Health/Medical Writers BIOWIRE2K SEATTLE--(BW HealthWire)--Sept. 6, 2001 Dendreon Corporation (Nasdaq:DNDN) announced today the completion of patient enrollment in its first Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the of Provenge(TM), Dendreon's therapeutic vaccine therapeutic vaccine Immunology A vaccine–eg, Salk's Remune™ intended to treat a viral infection by stimulating the immune system. See Vaccine therapy. for the treatment of advanced hormone resistant prostate cancer prostate cancer, cancer originating in the prostate gland. Prostate cancer is the leading malignancy in men in the United States and is second only to lung cancer as a cause of cancer death in men. . Patient enrollment in a second similar Phase III clinical trial and preparation to file a Biologics License Application with the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. in 2002 for approval of Provenge are continuing. "We are pleased to have completed patient enrollment in our first Phase III clinical trial," said Christopher S. Henney, Ph.D., D.Sc., chief executive officer of Dendreon. "We anticipate that efficacy results from this trial will become available this year." Dendreon Corporation (www.dendreon.com) is dedicated to the discovery and development of novel products for the treatment of cancer through its innovative manipulation of the immune system immune system Cells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders. . Dendreon currently has two other therapeutic cancer vaccine candidates in clinical trials -- Mylovenge(TM), for the treatment of multiple myeloma multiple myeloma A malignant proliferation of abnormal plasma cells that populate the marrow-containing bones of the body. The affected plasma cells produce myeloma protein, a monoclonal antibody that replaces normal antibodies in the blood, thereby increasing susceptibility , in Phase II trials; and APC (1) (American Power Conversion Corporation, West Kingston, RI, www.apcc.com) The leading manufacturer of UPS systems and surge suppressors, founded in 1981 by Rodger Dowdell, Neil Rasmussen and Emanual Landsman, three electronic power engineers who had worked at MIT. 8024, for the treatment of breast, ovarian and colon cancers, in Phase I trials. For information about participating in Dendreon's clinical trials, please visit the Company's website at www.dendreon.com or call 206/829-1640. Except for historical information contained herein, this news release contains forward-looking statements that are subject to risks and uncertainties that may cause actual results to differ materially from the results discussed in the forward-looking statements, particularly those 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 a difference include risks related to Dendreon's limited operating history, risks associated with completing our clinical trials, the risk that the safety and/or efficacy results of a clinical trial will not support an application for a biologics license, the risk that the FDA will not approve a product for which a biologics license has been applied, 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 SEC Reports, including Dendreon's Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. , and Form 10-Q for the second quarter of 2001, which are available at www.sec.gov. |
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