SEATTLE and SAN FRANCISCO, May 31 /PRNewswire-FirstCall/ -- Dendreon Corporation today announced the presentation of safety data from the integrated analysis of four randomized PROVENGE® (sipuleucel-T) clinical trials of an autologous cellular immunotherapy in prostate cancer at the 105th Annual Scientific Meeting of the American Urological Association (AUA) in San Francisco.
"The approval of PROVENGE provides us with an important new, front-line option for men with asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer," said Simon Hall, M.D., director of the Barbara and Maurice Deane Prostate Health and Research Center at Mount Sinai Medical Center.
The analysis includes data from four randomized trials in patients with either metastatic castrate resistant prostate cancer (Studies D9901, D9902A, IMPACT) or androgen dependent prostate cancer (Study P-11) that were integrated to examine the safety profile of PROVENGE across the four studies. The safety evaluation of PROVENGE was based on 601 prostate cancer patients in four randomized clinical trials who underwent at least one leukapheresis procedure. The abstract presented was a poster presentation by Dr. Hall, titled "Integrated safety results from 4 randomized, double-blind, placebo-controlled studies of sipuleucel-T (abstract #1000875)."
PROVENGE is the first autologous cellular immunotherapy to be approved by the U.S. Food and Drug Administration for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.
PROVENGE Important Safety Information
PROVENGE is intended solely for autologous use and is not routinely tested for transmissible infectious diseases.
In controlled clinical trials, serious adverse events reported in the PROVENGE group include acute infusion reactions (occurring within 1 day of infusion) and cerebrovascular events. Severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting. No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group.
The most common adverse events (incidence greater than or equal to 15%) reported in the PROVENGE group are chills, fatigue, fever, back pain, nausea, joint ache, and headache.
To fulfill a post marketing requirement and as a part of the company's ongoing commitment to patients, Dendreon will conduct a registry of approximately 1,500 patients to further evaluate a small potential safety signal of cerebrovascular events. In four randomized clinical trials of PROVENGE in prostate cancer patients, cerebrovascular events were observed in 3.5% of patients in the PROVENGE arm compared with 2.6% of patients in the control arm.
About Active Cellular Immunotherapy
PROVENGE is classified by the FDA as an autologous cellular immunotherapy. It is designed to be an active cellular immunotherapy. Active cellular immunotherapy is designed to stimulate a T-cell response to cancer cells. An immune response is started by a specialized class of immune system cells called antigen-presenting cells (APCs). APCs take up antigen from their surroundings and process the antigen into fragments that are then displayed on the APC surface. Once displayed, these antigens can be recognized by specific classes of immune cells called T lymphocytes (T-cells), which are activated as a result of their engagement with APCs and combat disease by seeking antigen-bearing cells directly. PROVENGE is designed to target the prostate cancer antigen prostatic acid phosphatase (PAP), an antigen that is expressed in more than 95 percent of all prostate cancers.
About Dendreon
Dendreon Corporation is a biotechnology company targeting cancer and transforming lives through the discovery, development, commercialization and manufacturing 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 in a variety of tumor types. Dendreon's first autologous cellular immunotherapy product, PROVENGE® (sipuleucel-T), was approved by the FDA in April 2010 for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer. Dendreon also is developing an orally-available small molecule that targets TRPM8 that could be applicable to multiple types of cancer. The Company is headquartered 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/
This news release contains forward-looking statements that are subject to risks and uncertainties. Factors that could affect these forward-looking statements include, but are not limited to, developments affecting Dendreon's business and prospects, including commercialization of PROVENGE. 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 cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to Dendreon on the date hereof, and Dendreon undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.
Dendreon Corporation
CONTACT: Katherine Stueland, Vice President, Corporate Communications
and Investor Relations of Dendreon Corporation, +1-206-829-1522,
kstueland@dendreon.com
Web Site: http://www.dendreon.com/
