SEATTLE and CHICAGO, May 20 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN) today announced the upcoming presentation of data from integrated analyses of three Phase 3 PROVENGE® (sipuleucel-T) clinical trials of an autologous cellular immunotherapy in advanced prostate cancer, to be presented at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago on Monday, June 7 at 8:00 a.m. CT.
"With the recent FDA approval of PROVENGE for asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer, patients now have a new treatment option available that prolongs survival," said Daniel P. Petrylak, M.D., program director of the Genitourinary Oncology Section in the Division of Hematology/Oncology at Columbia University. "Cancer immunotherapy represents an entirely new era in medicine and patient care."
The exploratory analyses include data from three Phase 3 trials in patients with metastatic castrate resistant prostate cancer (Studies D9901, D9902A, and IMPACT) that were integrated to examine the treatment effect in a larger group of patients, the use of docetaxel before and after randomization, and relationships between certain product parameters and clinical outcome. These include:
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 is intended solely for autologous use and is not routinely tested for transmissible infectious diseases.
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 most common adverse events (incidence greater than or equal to 15%) are chills, fatigue, fever, back pain, nausea, joint ache, and headache. Serious adverse events reported in the PROVENGE group include acute infusion reactions (occurring within 1 day of infusion) and cerebrovascular events. In controlled clinical trials, 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.
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 group compared with 2.6% of patients in the control group.
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.
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 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 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.
|SOURCE Dendreon Corporation|
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