SEATTLE, Aug. 14 /PRNewswire-FirstCall/ -- 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 Neo
|SOURCE Dendreon Corporation|
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