Healthcare Industry News: sipuleucel-T
News Release - August 24, 2006
Dendreon Submits Clinical and Non-Clinical Sections of Rolling BLA to FDA for PROVENGE to Treat Advanced Prostate Cancer PatientsSEATTLE, Aug. 24 (HSMN NewsFeed) -- Dendreon Corporation (Nasdaq: DNDN ) today announced that the Company has submitted the clinical and non-clinical sections of the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for PROVENGE® (sipuleucel-T) for the treatment of asymptomatic patients with metastatic, androgen-independent (also known as hormone-refractory) prostate cancer. The Company plans to submit the chemistry, manufacturing and controls (CMC) section later this year, which will complete the submission of the BLA to the FDA for approval to market PROVENGE.
The clinical section of the BLA contains the evidence supporting the safety and efficacy of PROVENGE for the treatment of men with advanced prostate cancer. In particular, this section of the BLA contains the clinical trial data supporting the conclusion that PROVENGE confers an advantage in overall survival, without significant toxicity, to men with asymptomatic, metastatic, androgen-independent prostate cancer.
"Prostate cancer is the second leading cause of cancer death in American men and remains a serious unmet medical need with few effective treatment options," said Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. "Based upon the results of our clinical trials, we believe that PROVENGE has a highly favorable benefit-to-risk profile, and we are focused on working closely with the FDA so that PROVENGE can be made available to help prostate cancer patients."
The FDA has granted Fast Track review status to PROVENGE enabling Dendreon to submit its BLA on a rolling basis so the FDA can review sections before receiving the complete submission. If approved, PROVENGE would become the first commercially available active immunotherapy, sometimes referred to as therapeutic cancer vaccine, to treat advanced hormone-refractory prostate cancer.
Prostate cancer is the most common non-skin cancer in the United States and the third most common cancer worldwide. More than one million men in the United States have prostate cancer, with an estimated 232,000 new cases of prostate cancer diagnosed each year. More than 30,000 men die each year of the disease.
PROVENGE (sipuleucel-T) is an investigational product that is designed to stimulate a patient's own immune system to recognize and destroy prostate cancer cells. It is currently being evaluated for the treatment of patients with early- and advanced-stage prostate cancer. In clinical studies, patients typically are randomized to receive three infusions of PROVENGE or placebo over a one-month period as a complete course of therapy.
A double-blind, placebo-controlled Phase 3 Study (D9901) published in the July 2006 issue of the Journal of Clinical Oncology found that the group of asymptomatic men with metastatic, androgen-independent prostate cancer who received PROVENGE had a median survival time 4.5 months longer than the median survival seen in the group that had been assigned to receive placebo. For the men who received PROVENGE, there was a 41 percent overall reduction in the risk of death (p-value = 0.010; HR = 1.7). In addition, 34 percent of patients receiving PROVENGE were alive 36 months after treatment compared to 11 percent of patients randomized to receive placebo.
Treatment with PROVENGE was generally well tolerated. In controlled clinical trials, the most common adverse reactions associated with PROVENGE were chills, fever, headache, fatigue, shortness of breath, vomiting and tremor. These events were primarily low grade events, with a short duration lasting 1 to 2 days following infusion.
About Active Immunotherapy
Active immunotherapy holds promise because it may provide patients with a meaningful clinical benefit, such as survival, combined with low toxicity. To develop its active immunotherapy, Dendreon utilizes proprietary technology to modify, or engineer, tumor antigens as recombinant proteins. Dendreon combines these recombinant proteins with a patient's own immune system cells so that the tumor antigens are recognized by the immune system, generating an antitumor response.
Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development and commercialization of novel therapeutics that harness the immune system to fight cancer. The Company applies its expertise in antigen identification, engineering and cell processing to produce active immunotherapy product candidates designed to stimulate a cell-mediated immune response. The Company has headquarters in Seattle and is traded on The NASDAQ National Market® under the symbol DNDN. 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 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 differences include risks related to our 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 may interpret data differently than we do or require more data or a more rigorous analysis of data than expected, the risk that the FDA will not 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 or commercialization of PROVENGE, our dependence on the efforts of third parties, 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, which are available at www.sec.gov .
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