Dendreon Corporation Presents Provenge Data at Prostate Cancer Foundation Meeting.Business Editors/Health/Medical Writers BIOWIRE2K SEATTLE--(BUSINESS WIRE)--Nov. 10, 2003 Dendreon Corporation (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :DNDN) announced that it presented previously reported data from the completed Phase 3 trial of its investigational immunotherapy Provenge(R) for the treatment of androgen androgen (ăn`drəjən): see testosterone. androgen Any of a group of hormones that mainly influence the development of the male reproductive system. independent 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. at the Prostate Cancer Foundation (formerly CaP CURE) 10th Annual Scientific Retreat taking place in New York City New York City: see New York, city. New York City City (pop., 2000: 8,008,278), southeastern New York, at the mouth of the Hudson River. The largest city in the U.S. on November 8 -10, 2003. The conference gathers scientific thought leaders in prostate cancer research for a review and discussion of the latest clinical data, new discoveries and emerging treatment strategies. The presentation, titled "Interim Survival Analysis of Data from a Phase 3 Trial of 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 (Provenge) in Androgen Independent Prostate Cancer" provided an overview of the previously released preliminary survival data from the randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , double blind, placebo-controlled Provenge trial, D9901. This data show a median survival time of 26.3 months for patients treated with Provenge compared to 19.3 months for those receiving only placebo, for a survival benefit of 7 months. Extended survival of 4.6 months was also noted among patients who initially received placebo, experienced disease progression and subsequently were treated with active therapy in a crossover protocol. In addition, previously reported data from the Provenge D9901 trial showed significant clinical benefit from Provenge treatment for men 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. For these men, the probability of remaining progression-free while on the study was over two times higher than for patients treated with placebo (p = 0.001), and the probability of remaining free of cancer-related pain cancer-related pain, n pain with acute, chronic, and psychological aspects experienced by cancer patients. Associated with the disease process and treatment. while on the study was over two-and-one-half times higher than for patients receiving placebo (p = 0.016). Treatment was well tolerated, with mild infusion-related fevers and chills the most common adverse events. "We are pleased to have the opportunity to present our promising Provenge data at the prestigious Prostate Cancer Foundation meeting," said Mitchell H. Gold, M.D., chief executive officer of Dendreon. "Meetings such as this provide a key catalyst for accelerating the advance of potential new treatments for prostate cancer." Provenge is currently in a pivotal double blind, placebo-controlled Phase 3 trial, D9902B. To be eligible for the study, patients must have 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. prostate cancer that has progressed following hormone therapy Hormone therapy Treating cancers by changing the hormone balance of the body, instead of by using cell-killing drugs. Mentioned in: Breast Cancer, Thyroid Cancer hormone therapy and have a Gleason Score of 7 or less. Patients must also be free of cancer-related pain. Prostate cancer is one of the most common cancers diagnosed among men in the United States. More than one million men in the United States have prostate cancer, with an estimated 220,000 cases diagnosed and 28,900 deaths in 2003. There are currently no products FDA-approved for slowing or stopping the progression of androgen independent prostate cancer or delaying the onset of disease-related pain. Dendreon Corporation is a biotechnology company developing targeted therapies for cancer. In addition to its immunotherapies in clinical and preclinical development for a variety of cancers, Dendreon's product pipeline also includes 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 , small molecule and prodrug prodrug /pro·drug/ (-drug) a compound that, on administration, must undergo chemical conversion by metabolic processes before becoming an active pharmacological agent; a precursor of a drug. product candidates. Dendreon has research and development alliances with Genentech, Inc., Kirin Brewery Co., Ltd., Abgenix, Inc. and Dyax Corp. 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 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, the risk that preliminary analyses of data may not be confirmed by final data, 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 public disclosure filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. |
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