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Dendreon Completes Enrollment in Phase 3 PROTECT (P-11) Clinical Trial of Provenge in Early Stage Prostate Cancer

Posted on: Tuesday, 21 June 2005, 12:00 CDT

SEATTLE, June 21 /PRNewswire-FirstCall/ -- Dendreon Corporation today announced that the Company has completed enrollment in its Phase 3 PROTECT (P-11) clinical trial of Provenge(R) (APC8015) in men with non-metastatic androgen-dependent (hormone-sensitive) prostate cancer. Provenge is the Company's investigational immunotherapy for the treatment of prostate cancer. Over 170 men with non-metastatic androgen-dependent prostate cancer continue to be followed as part of this study.

"This is another in a series of important milestone achievements we have made in the comprehensive development of Provenge," said Mitchell H. Gold, M.D., Dendreon's president and chief executive officer. "We thank the many patients, physicians and their teams who are participating in and making this important trial possible. Provenge is currently the only cancer immunotherapy being studied in early stage prostate cancer in a Phase 3 study. We anticipate that we will be able to complete the analysis of the trial and provide initial results during the first half of 2006."

Study Details

The study, known as PROTECT (PROvenge Treatment and Early Cancer Treatment) or P-11, is a double-blind, placebo-controlled Phase 3 trial designed to evaluate Provenge in men with non-metastatic androgen-dependent prostate cancer. It is measuring PSA progression and the onset of metastatic disease. At the time of biochemical progression, men become eligible for one booster of either Provenge or placebo. The study is being conducted at 19 institutions in the United States and has enrolled over 170 men.

About Provenge

Provenge is designed to stimulate a patient's immune system 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 (PAP).

A recently reported Phase 3 trial, known as D9901, showed that Provenge significantly improved survival in men with asymptomatic, metastatic androgen-independent (hormone-refractory) prostate cancer when compared to patients receiving placebo. Provenge is being further evaluated in an ongoing Phase 3 study in this patient population, known as D9902B.

About Dendreon

Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the development of innovative cancer treatments. In addition to its immunotherapies in clinical and preclinical development for a variety of cancers, Dendreon's product pipeline also includes monoclonal antibody and small molecule product candidates. Dendreon has research and development alliances with Genentech, Inc., Abgenix, Inc. and Dyax Corp. For more information about the company and its programs, visit http://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, 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, which are available at http://www.sec.gov/.

Dendreon Corporation

CONTACT: Monique M. Greer, Sr. Director, Corporate Communications ofDendreon Corporation, +1-206-829-1500

Web site: http://www.dendreon.com/

Source: PRNewswire-FirstCall

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