Dendreon Presents at the 7th International Symposium on Dendritic Cells in Bamberg, Germany.Business Editors & Health/Medical Writers BAMBERG, Germany--(BUSINESS WIRE)--Sept. 23, 2002 Dendreon Corporation (Nasdaq:DNDN) today announced that Reiner Laus, M.D., the company's vice president of research, addressed the 7th International Symposium on Dendritic Cells taking place September 21-24 in Bamberg, Germany. In his presentation, Laus discussed results of the first double blind, placebo-controlled, 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 trial of Provenge, 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 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. . The trial, involving 127 men with the most advanced form of prostate cancer, demonstrated significant clinical benefit in patients with a Gleason score Gleason score Oncology A value derived from the Gleason grading system which is the sum of the 2 most predominant histologic patterns seen in prostate CA of 7 or less. These patients demonstrated a median time to disease progression of 16.0 weeks compared to 9.0 weeks for the placebo group for a treatment effect of 78%. In addition, those patients receiving Provenge whose disease had not progressed six months after randomization randomization (ranˈ·d  ·m had a greater than eight-fold advantage in disease-free survival disease-free survival Oncology The time that a person with a disease lives without known recurrence; DFS is major clinical parameter used to evaluate the efficacy of a particular therapy, which is usually measured in 'units' of 1 or 5 yrs. See Cure, Remission. compared to those patients receiving placebo (34.7 percent versus 4 percent). Treatment with Provenge was well tolerated, with the most common side effects Side effects Effects of a proposed project on other parts of the firm. being fevers and chills, which were most often infusion-related. To date, more than 400 patients have been enrolled in clinical trials of Provenge. Laus also discussed Dendreon's proprietary approach for developing immunotherapeutic cancer vaccines Cancer vaccines A treatment that uses the patient's immune system to attack cancer cells. Mentioned in: Pancreatic Cancer, Exocrine . This includes identifying and engineering tumor antigens as recombinant proteins and delivering these to patients via Dendreon's patented Antigen Delivery Cassette(TM) to be recognized by 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. . About Provenge Provenge is an investigational therapeutic cancer vaccine designed to jumpstart a person's natural defenses against prostate cancer. It is developed through Dendreon's proprietary Antigen Delivery Cassette(TM) technology, which utilizes a recombinant form of an antigen found in 95 percent of prostate cancers, prostatic acid phosphatase Prostatic acid phosphatase (PAP) is an enzyme produced by the prostate. It may be found in increased amounts in men who have prostate cancer or other diseases. This is also the same enzyme that is found in significant amounts in female ejaculate. (PAP). About Dendreon Dendreon Corporation is a biotechnology company developing targeted therapies for cancer. Dendreon currently has three therapeutic vaccines in clinical trials. Dendreon's product pipeline also includes monoclonal antibodies and a pathway to small molecules. Dendreon has established important alliances with industry leaders Genentech, Johnson & Johnson Pharmaceutical Research & Development and Kirin Brewery Co., Ltd. For more information, visit www.dendreon.com. 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 surrounding the efficacy of Provenge to treat men suffering from prostate cancer, risks and uncertainties surrounding the presentation of data to 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. 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 a difference include risks related to Dendreon's limited operating history, risks associated with completing our clinical trials, including the risk that the FDA may not lift the partial clinical hold on enrollment in our second Phase III trial of Provenge (D9902), 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 will not be satisfied with the data we provide for Provenge or 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 for Provenge, dependence on the efforts of third parties, including collaborators, 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, which are available at www.sec.gov. |
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