<0> Dendreon CorporationLindsay Rocco, 862-596-1304Corporate Communications </0>
– Dendreon Corporation (NASDAQ:) today announced the presentation of four PROVENGE (sipuleucel-T) abstracts and one abstract for DN24-02, an investigational active cellular immunotherapy, from ongoing clinical trials at the 2014 Genitourinary Cancers Symposium (ASCO GU) from January 30-February 1, 2014 in San Francisco, California.
“The PROVENGE and DN24-02 research presented at this year's ASCO GU Symposium demonstrate Dendreon's ongoing commitment to our immuno-oncology franchise and patients in need of new and innovative treatment options for cancer,” said Andrew S. Sandler, M.D., executive vice president and chief medical officer at Dendreon. “These data further elucidate the mechanism underlying the PROVENGE treatment effect and further our understanding of the role of immunotherapy in cancer treatment.”
The data featuring PROVENGE and DN24-02 studies include:
“Data from the Phase III IMPACT study demonstrate that treatment with sipuleucel-T may result in humoral antigen spread, which was found to be associated with improved overall survival,” said Daniel Petrylak, M.D., professor of medicine, director of Genitourinary Oncology, co-director of Signal Transduction Research Program, Yale Cancer Center and Smilow Cancer Hospital at Yale New Haven. “These results are particularly exciting because they further our understanding of the sipuleucel-T mechanism of action and may enable identification of post-treatment biomarkers of clinical outcome.”
PROVENGE (sipuleucel-T) is an autologous cellular immunotherapy indicated 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. 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 1500 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 or call 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 (sipuleucelT), was approved by the U.S. Food and Drug Administration (FDA) in April 2010. 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 .