Advertisement
All patients will receive active treatment but will be randomized into oneof three cohorts which will receive PROVENGE manufactured with differentconcentrations of the immunizing antigen. Patients will receive threeinfusions of PROVENGE, each two weeks apart. The trial is being conducted byDendreon to explore the effect of antigen concentration on CD54 upregulation,a measure of product potency, as well as the immune response. Overall survivaldata will also be collected. The enrollment criteria are essentially the sameas the criteria for the Phase 3 IMPACT (IMmunotherapy for ProstateAdenoCarcinoma Treatment, also known as D9902B) study, which completedenrollment in October 2007 and, upon receipt of positive data, will serve asthe primary study for amending Dendreon's Biologics License Application (BLA)for PROVENGE.
Advertisement
"We are grateful for the continued support from patients, physicians andpatient advocates and are pleased to be able to provide them with access toPROVENGE 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. Dendreonrecently 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 ComprehensiveCancer Center.
About Prostate Cancer
Prostate cancer is the most common non-skin cancer in the United Statesand the third most common cancer worldwide. More than one million men in theUnited States have prostate cancer, with an estimated 186,320 new casesexpected to be diagnosed in 2008, and approximately 28,660 men expected to diethis year from the disease. Currently there are limited treatment options formen with advanced, metastatic prostate cancer.
About Active Cellular Immunotherapy with PROVENGE
PROVENGE may represent the first product in a new class of active cellularimmunotherapies (ACIs) that are uniquely designed to use live human cells toengage the patient's own immune system with the goal of eliciting a specificlong-lasting response against cancer. Active cellular immunotherapy holdspromise 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 targetcancer and transform lives through the discovery, development andcommercialization of novel therapeutics. The Company applies its expertise inantigen identification, engineering and cell processing to produce activecellular immunotherapy product candidates designed to stimulate an immuneresponse. Dendreon is also developing an orally-available small molecule thattargets Trp-p8 that could be applicable to multiple types of cancer as well asbenign 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, visithttp://www.dendreon.com.
Except for historical information contained herein, this news releasecontains forward-looking statements that are subject to risks anduncertainties surrounding the efficacy of PROVENGE to treat men suffering fromprostate cancer, risks and uncertainties surrounding the presentation of datato the FDA and approval of product a
