All, it looks like Dendreon is moving onward to get Provenge approved by theFDA. The press release also mentions some on-going clinical trials which youwill have to search for at www.clinicaltrials. gov (I would guess thatProACT would be the most likely "fit". ) Take care,HowardDendreon Completes Submission of Biologics License Application for PROVENGE SEATTLE (November 2, 2009) - Dendreon Corporation (Nasdaq: DNDN) todayannounced that it has completed the submission of the amended BiologicsLicense Application (BLA) for PROVENGER (sipuleucel- T), the Company's leadinvestigational product, to the U.S. Food and Drug Administration (FDA).Dendreon is seeking licensure for PROVENGE for men with metastaticcastrate-resistant prostate cancer (CRPC). If approved by the FDA, PROVENGEwould represent the first product in the new therapeutic class known asactive cellular immunotherapies. The amended BLA includes data from the IMPACT (IMmunotherapy for ProstateAdenoCarcinoma Treatment) trial, which was conducted under a SpecialProtocol Assessment agreement with the FDA. The IMPACT study met itspre-specified primary endpoint demonstrating a statistically significantimprovement in overall survival in men with metastatic CRPC. "With the BLA submission complete, we have taken an important step towardsreaching our goal of bringing a new therapy to men with advanced prostatecancer," said Mitchell H. Gold, MD, president and chief executive officer ofDendreon. "We look forward to working with the FDA to potentially makePROVENGE the first active cellular immunotherapy to be licensed in theUnited States." PROVENGE is available through several ongoing clinical trials, includingopenACT, an open label trial enrolling men with metastatic CRPC, ProACT(PROstate cancer Active Cellular immunoTherapy) , and NeoACT (NEOadjuvantActive Cellular immunotherapy) . For more information regarding thesestudies, visit www.clinicaltrials. gov.about PROVENGEPROVENGE is Dendreon's investigational product candidate for men withadvanced prostate cancer and may represent the first in a new class ofactive cellular immunotherapies (ACIs) specifically designed to engage thepatient's own immune system against cancer. PROVENGE and other ACIs areuniquely designed to use live human cells to engage the patient's own immunesystem with the goal of eliciting a specific long-lasting response againstcancer. about Prostate CancerAccording to the American Cancer Society, prostate cancer is the most commonnon-skin cancer in the United States and the third most common cancerworldwide. More than one million men in the United States have prostatecancer. An estimated 192,280 new cases are expected to be diagnosed in 2009.Approximately 27,360 men are expected to die this year from the disease.
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