Dendreon Corporation Receives FDA Fast Track Designation for Provenge.Business Editors/Health/Medical Writers BIOWIRE2K SEATTLE--(BUSINESS WIRE)--Sept. 4, 2003 Dendreon Corporation (Nasdaq:DNDN) today announced that the U.S. Food and Drug Administration (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. ) has designated the Company's investigational immunotherapy Provenge(R) as a Fast Track development program for the treatment of asymptomatic, 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. , 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. . The designation of Provenge under Fast Track means that the FDA will take appropriate actions to expedite the development and review of a potential Biologics License Application for approval of Provenge in the target indication. Specifically, Fast Track designation allows for a rolling submission of a potential Biologics License Application with the FDA for Provenge and ordinarily provides for a priority review. A priority review as defined by the FDA is a six-month review cycle. Provenge is currently in a pivotal double blind placebo-controlled Phase 3 trial seeking to confirm previous results that indicate the product may delay progression of disease and the development of disease-related pain. Dendreon has received a positive assessment from the FDA under the Special Protocol Assessment (SPA) provision indicating the trial, D9902B, may serve as the basis for a Biologics License Application for Provenge. "The designation of Provenge as a Fast Track program by the FDA validates its promise to address a serious unmet medical need for the treatment of advanced, asymptomatic androgen independent prostate cancer," said Mitchell H. Gold, M.D., Chief Executive Officer. "This designation combined with the receipt of the SPA agreement for our pivotal Phase 3 trial and last year's successful review of the product characterization are significant regulatory milestones and mechanisms that may increase the speed with which Provenge can be brought to market." Dendreon submitted the Fast Track application with the FDA for Provenge based on positive results from the double blind, placebo-controlled Phase 3 trial, D9901. Results of the trial demonstrated significant clinical benefit from Provenge treatment for men with androgen independent prostate cancer (AIPC AIPC Androgen-Independent Prostate Cancer AIPC American Italian Pasta Company (Kansas City, MO) AIPC Aquidneck Island Planning Commission (Rhode Island) ) 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 and 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 more than two times higher than for patients treated with placebo. Supporting these clinical results were findings confirming the mechanism of action based on the 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. stimulated by Provenge treatment. Among men treated with Provenge, those with a Gleason score of 7 or less demonstrated a T-cell mediated immune response 7-fold greater than the immune response in men with a Gleason score of 8 or more. Treatment was well tolerated, with mild infusion-related fevers and chills the most common adverse events. Provenge Pivotal Trial A double blind, placebo controlled Phase 3 trial of Provenge is underway at medical centers throughout the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. . To be eligible for the study, patients must have metastatic 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. Information on Dendreon's clinical trials is available at www.dendreon.com. About Provenge Provenge is designed to stimulate a person's 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. 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 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 189,000 cases diagnosed and 30,200 deaths in 2002. There is currently no available therapeutic treatment for asymptomatic metastatic androgen independent prostate cancer. About Gleason Score The Gleason score is the most commonly used prostate cancer scoring system Noun 1. scoring system - a system of classifying according to quality or merit or amount rating system classification system - a system for classifying things and is considered one of the most important prognostic prog·nos·tic adj. 1. Of, relating to, or useful in prognosis. 2. Of or relating to prediction; predictive. n. 1. A sign or symptom indicating the future course of a disease. 2. indicators for prostate cancer. The score is based on tissue findings throughout the prostate that correlate with the aggressiveness of a tumor. High Gleason scores are indicative of aggressive cancers and are not associated with a favorable prognosis. In the androgen independent patient population approximately 75 percent of the patients have a Gleason score of 7 or less. Dendreon Corporation is a biotechnology company developing targeted therapies for cancer. The company's lead investigational product candidate is Provenge(R). 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 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 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 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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