Dendreon Announces Presentation of Promising Provenge Phase III Clinical Trial Results at 9th Annual CaP CURE Scientific Retreat.Business Editors, Health/Medical Writers BIOWIRE2K WASHINGTON--(BUSINESS WIRE)--Sept. 20, 2002 Results Demonstrate First Evidence of Clinical Efficacy of Cancer Vaccine The term cancer vaccine is often used to describe a process whereby a person's immune system is coaxed into recognizing and destroying malignant cells without harming normal cells. in 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. Dendreon Corporation (Nasdaq:DNDN) announced that the promising results of its first 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(TM) (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. 8015), the company's investigational vaccine for the treatment of hormone resistant prostate cancer, will be presented later today at the 9th Annual CaP CURE Scientific Retreat. Eric J. Small, M.D., professor of medicine and urology urology Medical specialty dealing with the urinary system and male reproductive organs. It traces its origin to medieval lithologists, itinerant healers who specialized in surgical removal of bladder stones. at the University of California The University of California has a combined student body of more than 191,000 students, over 1,340,000 living alumni, and a combined systemwide and campus endowment of just over $7.3 billion (8th largest in the United States). San Francisco and the trial's principal investigator, will provide the first scientific presentation of the latest data on Provenge, which to date has been studied in trials enrolling more than 400 patients. Provenge is based on a new biologic approach that uses the body's own 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. to treat men suffering from the most advanced form of prostate cancer. The results showed that men with hormone resistant prostate cancer who have 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, which accounts for approximately 75 percent of hormone resistant patients, significantly benefited from Provenge treatment. "The results of this study are promising," said Small. "There exist only a small number of options for the treatment of advanced prostate cancer patients, so that the potential development of relatively non-toxic immunologic therapy is exciting." The trial involved 127 men with metastatic Metastatic The term used to describe a secondary cancer, or one that has spread from one area of the body to another. Mentioned in: Coagulation Disorders metastatic pertaining to or of the nature of a metastasis. , hormone resistant prostate cancer, 82 of whom received Provenge. All patients enrolled in the trial had advanced prostate cancer and most had failed all conventional medical and surgical therapy options at the time they were enrolled. The primary endpoint for the study was time to objective disease progression. In patients with a Gleason score less than or equal to 7 (the most prevalent category in prostate cancer patients), the placebo group had a median time to disease progression of 9.0 weeks compared to 16.0 weeks in the Provenge treated group, with a highly significant p-value of 0.002 and a treatment effect of 78 percent. 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 progression-free survival compared to those patients who received placebo (34.7 percent versus 4 percent). Overall, Provenge was well tolerated by patients, with the most common side effects Side effects Effects of a proposed project on other parts of the firm. being chills and fever Noun 1. chills and fever - successive stages of chills and fever that is a symptom of malaria ague malaria - an infective disease caused by sporozoan parasites that are transmitted through the bite of an infected Anopheles mosquito; marked by paroxysms of , which were most often infusion-related. About Prostate Cancer Prostate cancer is the leading cancer diagnosed among men in the United States. More than one million men in the United States have prostate cancer, with 200,000 cases diagnosed and 31,500 deaths in 2001. There is currently no available treatment for hormone resistant prostate cancer. 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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