SEATTLE, May 18, 2011 /PRNewswire/ -- Dendreon Corporation (Nasdaq: DNDN) today announced the following PROVENGE® (sipuleucel-T) data presentations taking place at the 2011 American Society of Clinical Oncology annual meeting in Chicago, Illinois.
- "Time to Disease-Related Pain After Sipuleucel-T in Asymptomatic Patients with Metastatic Castrate-Resistant Prostate Cancer (mCRPC): Results from 3 Randomized Phase 3 Trials," abstract #4661. McCormick Place Hall A (Poster 12E) from 8:00 a.m. to 12:00 p.m. CT on Sunday, June 5, 2011.
- "Quality of Life Assessment in Randomized, Double-Blind Study of Sipuleucel-T in Men with Androgen Dependent Prostate Cancer," abstract #4648. McCormick Place Hall A (Poster 10H) from 8:00 a.m. to 12:00 p.m. CT on Sunday, June 5, 2011.
- "Post-Progression Treatment with APC8015F May Have Prolonged Survival of Subjects in the Control Arm of Sipuleucel-T Phase 3 Studies," abstract #4534. E450A from 2:00 to 6:00 p.m. CT on Saturday, June 4, 2011.
- "Sipuleucel-T in African Americans: a Subgroup Analysis of Three Phase 3 Sipuleucel-T Trials in Advanced Prostate Cancer," abstract #E15148. Publication only.
PROVENGE was approved by the U.S. Food and Drug Administration (FDA) in April 2010 as the first autologous cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.
"In addition to the significant survival benefit PROVENGE has demonstrated in Phase 3 clinical trials, the data analyses presented at the 2011 ASCO annual meeting provide further insight into the immunotherapy's potential impact on patient sub-groups, as well as clinically important factors like time to disease-related pain and quality of life," said Mark Frohlich, M.D., executive vice president of research and development and chief medical officer of Dendreon. "The data analyses in patients with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer continue to support the use of PROVENGE as a foundation of care in this patient population."
PROVENGE Indication and Safety
PROVENGE is an autologous cellular immunotherapy 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%) reported in patients in the PROVENGE group are chills, fatigue, fever, back pain, nausea, joint ache, and headache. Serious adverse events reported in patients 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.
For more information on PROVENGE, please see the full Prescribing Information at www.provenge.com or call Dendreon ON Call at 1-877-336-3736
Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform 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 (ACI) product candidates designed to stimulate an immune response in a variety of tumor types. Dendreon's first product, PROVENGE® (sipuleucel-T), was approved by the U.S. Food and Drug Administration (FDA) in April 2010 for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer. Dendreon is exploring the application of additional ACI product candidates and small molecules for the potential treatment of a variety of cancers. 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 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