SEATTLE, July 16 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN) today announced that the Company has initiated a Phase 2 trial of PROVENGE(R) (sipuleucel-T), Dendreon's investigational active cellular immunotherapy for the treatment of prostate cancer, in men with localized prostate cancer who are scheduled to undergo a radical prostatectomy. The single-center trial called NeoACT (NEOadjuvant Active Cellular immunoTherapy), or P07-1, which is being conducted at UCSF Helen Diller Family Comprehensive Cancer Center, has begun enrolling approximately 40 patients. NeoACT is the first of two new Phase 2 trials of PROVENGE being initiated this year.
Each patient will receive a complete course of active treatment over a one-month period beginning six to seven weeks prior to the patient's radical prostatectomy. The course of treatment will consist of three infusions of PROVENGE-two weeks apart. Multiple safety and efficacy endpoints will be evaluated including the immune response in the prostatectomy specimens and in the peripheral blood. Following radical prostatectomy, patients will be randomized to receive either a booster of PROVENGE or no booster. Patients interested in additional information about this trial may visit http://www.clinicaltrials.gov and use the search term "NeoACT."
"I am pleased to help lead the NeoACT clinical trial, given the therapeutic potential of immunotherapy for prostate cancer," stated Lawrence Fong, M.D., principal investigator of the NeoACT trial and associate professor of medicine at UCSF Helen Diller Family Comprehensive Cancer Center. "This study will provide a unique opportunity to examine the immune response to PROVENGE in actual prostate cancer tissue and to examine the correlation between immune responses in the tissue versus those in the circulating blood."
"Given the evidence of a survival benefit seen in our previous Phase 3 trial, D9901, in patients with advanced prostate cancer, we believe PROVENGE may also have applicability to men with earlier stages of the disease. This trial will help us better understand the mechanism of action and biology of PROVENGE, as well as evaluate the potential of PROVENGE in patients at high-risk for recurrence of their cancer following radical prostatectomy," stated Mark Frohlich, M.D., senior vice president, clinical affairs and chief medical officer of Dendreon. "We are highly focused on taking the steps necessary to get PROVENGE through the FDA approval process in order to get this important immunotherapy to prostate cancer patients with advanced disease who do not have any other reasonable options. We are on track to complete the interim analysis of our ongoing Phase 3 IMPACT trial during the latter half of this year."
About 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 186,320 new cases expected to be diagnosed in 2008, and approximately 28,660 men expected to die this year from the disease. Currently there are limited treatment options for men with advanced, metastatic prostate cancer.
About Active Cellular Immunotherapy with PROVENGE
PROVENGE may represent the first product in a new class of active cellular immunotherapies (ACIs) that are uniquely designed to use live human cells to engage the patient's own immune system with the goal of eliciting a specific long-lasting response against cancer. Active cellular immunotherapy holds promise because it may provide patients with a meaningful clinical benefit, such as survival, combined with low toxicity.
Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development and commercialization of novel therapeutics. The Company applies its expertise in antigen identification, engineering and cell processing to produce active cellular immunotherapy product candidates designed to stimulate an immune response. Dendreon is also developing an orally-available small molecule called Trp-p8 that could be applicable to multiple types of cancer as well as benign prostatic hyperplasia. The Company has its headquarters in Seattle, Washington and is traded on the Nasdaq Global Market under the symbol DNDN. For more information about the Company and its programs, visit http://www.dendreon.com.
UCSF is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. For more information, please see http://www.ucsf.edu.
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 existing clinical trials or from additional clinical trials for PROVENGE will not support approval 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 http://www.sec.gov.
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