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Dendreon Corporation today announced that the Company has initiated its second of two new Phase 2 trials of PROVENGE(R) (sipuleucel-T)
SEATTLE, WA, USA | August 14, 2008 | Dendreon Corporation (Nasdaq: DNDN) today announced that the Company has initiated its second of two new Phase 2 trials of PROVENGE(R) (sipuleucel-T), Dendreon's investigational active cellular immunotherapy for the treatment of advanced prostate cancer. The multicenter trial, called ProACT (PROstate Active Cellular Therapy), has begun enrolling 120 patients with metastatic, androgen independent prostate cancer.
All patients will receive active treatment but will be randomized into one of three cohorts which will receive PROVENGE manufactured with different concentrations of the immunizing antigen. Patients will receive three infusions of PROVENGE, each two weeks apart. The trial is being conducted by Dendreon to explore the effect of antigen concentration on CD54 upregulation, a measure of product potency, as well as the immune response. Overall survival data will also be collected. The enrollment criteria are essentially the same as the criteria for the Phase 3 IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment, also known as D9902B) study, which completed enrollment in October 2007 and, upon receipt of positive data, will serve as the primary study for amending Dendreon's Biologics License Application (BLA) for PROVENGE.
"We are grateful for the continued support from patients, physicians and patient advocates and are pleased to be able to provide them with access to PROVENGE while we await results from the IMPACT trial," stated Mitchell H. Gold, president and chief executive officer of Dendreon.
ProACT is the second of two studies the Company is initiating. Dendreon recently announced it had begun enrolling patients in a 40-subject, single-center trial called NeoACT (NEOadjuvant Active Cellular immunoTherapy), or P07-1, which is being conducted at UCSF Helen Diller Family Comprehensive Cancer Center.
About Prostate Cancer
Prostate cancer is the most common non-skin cancer in the United States and the third most common cancer worldwide. More than one million men in the United States have prostate cancer, with an estimated 186,320 new cases expected to be diagnosed in 2008, and approximately 28,660 men expected to die this year from the disease. Currently there are limited treatment options for men with advanced, metastatic prostate cancer.
About Active Cellular Immunotherapy with PROVENGE
PROVENGE may represent the first product in a new class of active cellular immunotherapies (ACIs) that are uniquely designed to use live human cells to engage the patient's own immune system with the goal of eliciting a specific long-lasting response against cancer. Active cellular immunotherapy holds promise because it may provide patients with a meaningful clinical benefit, such as survival, combined with low toxicity.
About Dendreon
Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development and commercialization 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. Dendreon is also developing an orally-available small molecule that targets Trp-p8 that could be applicable to multiple types of cancer as well as benign prostatic hyperplasia. The Company has its headquarters 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.
SOURCE: Dendreon |
