Dendreon Corporation and Covance Biotechnology Services Inc. to Begin Provenge Cancer Vaccine Scale-Up.Business Editors & Health/Medical Writers BIOWIRE2K SEATTLE--(BW HealthWire)--April 5, 2001 -- Activities begin to scale-up to commercial-level production of antigen for therapeutic 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. vaccine -- Dendreon Corporation (Nasdaq:DNDN) today announced it will contract with Covance Biotechnology Services Inc. to produce antigen used in the preparation of Provenge(TM) -- Dendreon's prostate cancer vaccine that is currently in Phase III clinical trials. Under the agreement, Covance will work with Dendreon to produce antigen for commercial launch of Provenge. "This is an essential relationship to allow scale-up of our manufacturing capabilities to achieve production of Provenge at a commercial level. Covance is an experienced leader in providing top quality, recombinant protein recombinant protein Molecular biology A protein encoded by recombinant DNA or generated from a recombinant gene. See Recombinant pharmacology. and monoclonal antibody monoclonal antibody, an antibody that is mass produced in the laboratory from a single clone and that recognizes only one antigen. Monoclonal antibodies are typically made by fusing a normally short-lived, antibody-producing B cell (see immunity) to a fast-growing products for our industry," said David Urdal, Ph.D., Dendreon's President and Chief Scientific Officer. "With Provenge moving through Phase III Noun 1. phase III - 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 FDA trials, we are locking in place infrastructure that will serve us well." Provenge is currently in double-blind, placebo-controlled trials taking place at more than 30 medical centers nationwide. The trials, to involve a total of 240 patients with hormone refractory prostate cancer, are expected to complete patient enrollment this year. The therapeutic cancer vaccine is composed of a patient's own dendritic cells that are reinfused in combination with a specially engineered antigen to stimulate an immune response immune response n. An integrated bodily response to an antigen, especially one mediated by lymphocytes and involving recognition of antigens by specific antibodies or previously sensitized lymphocytes. against cancerous prostate tissue. 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. . In addition to Provenge, Dendreon has two therapeutic vaccines 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. Covance Biotechnology Services is a subsidiary of Covance Inc., one of the world's largest and most comprehensive drug development services companies. Covance Biotechnology Services provides a full range of bioprocessing services to the biopharmaceutical industry, including a variety of biological cell replication systems to produce proteins for clinical studies and commercial markets. 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 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, and 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. , which are available at www.sec.gov. www.dendreon.com |
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