Dendreon Highlights Provenge at American Association for Cancer Research Annual Meeting.Business Editors & Medical/Health Writers BIOWIRE2K 94th Annual Meeting of the American Association for Cancer Research WASHINGTON--(BUSINESS WIRE)--July 14, 2003 Results of First Phase 3 Trial Demonstrate Significant Clinical Benefit and 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. 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. Patients Dendreon Corporation (Nasdaq:DNDN) today presented a summary of results from its completed Phase 3 clinical trial phase 3 clinical trial Phase 3 study. See Phase study. of Provenge(R), the company's investigational 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. and lead product candidate for the treatment of prostate cancer, at the 94th Annual Meeting of the American Association for Cancer Research Wikipedia is not the place for advertisement or self-advertising. The American Association for Cancer Research (AACR) is an organization based in Philadelphia, Pennsylvania, that focuses on all aspects of cancer research including basic, clinical and translational in Washington, D.C. The double blind, placebo-controlled Phase 3 trial, D9901, was conducted in 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. 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 (AIPC AIPC Androgen-Independent Prostate Cancer AIPC American Italian Pasta Company (Kansas City, MO) AIPC Aquidneck Island Planning Commission (Rhode Island) ). The results of the 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, who comprise approximately 75 percent of the AIPC population. These men experienced a more than two-fold delay in both time to disease progression (Hazard Ratio 2.2, p=0.002) and time to development of disease-related pain (Hazard Ratio 2.6, p=0.019) compared to those patients receiving placebo. Supporting these clinical results were findings confirming the mechanism of action based on the immune response 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 men with a Gleason score of 8 or more (p=0.0065). Treatment was well tolerated, with mild infusion-related fevers and chills the most common adverse events. "The positive results from the D9901 trial provide some of the most complete information to date on patients with androgen independent prostate cancer, and the significant results in men with a Gleason score of 7 or less formed the basis of our second Phase 3 trial, D9902B, that is currently enrolling patients," said David Urdal, Ph.D., president and chief scientific officer of Dendreon. "Based on these strong clinical data and supporting biologic evidence collected, we recently received a binding agreement from 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. through the Special Protocol Assessment process that our current trial D9902B could support a Biologic License Application for Provenge approval." About D9902B Phase 3 Trial A double blind, placebo controlled Phase 3 trial of Provenge is underway at medical centers throughout the United States. 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 cancer-related pain, n pain with acute, chronic, and psychological aspects experienced by cancer patients. Associated with the disease process and treatment. . For information on participating in the Provenge trial, please call 1-866-4-PROSTATE (1-866-477-6782). Information on Dendreon's clinical trials is also available at www.dendreon.com. 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 hormone resistant prostate cancer. About Gleason Score The Gleason score is the most commonly used prostate cancer scoring system and is considered one of the most important prognostic 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. About Provenge Provenge is an investigational immunotherapy designed to stimulate a person'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. 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). Dendreon Corporation is a biotechnology company developing targeted therapies for cancer. In addition to its immunotherapies in clinical and pre-clinical development for a variety of cancers, Dendreon's product pipeline 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 and small molecule product candidates. Dendreon has established important research and development alliances with industry leaders Genentech, Inc. and Kirin Brewery Co., Ltd. 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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