Breaking the SPEED BARRIER ...DNDN Cancer Drug back in action 3 trials results..
three PROVENGE®(sipuleucel-T) abstracts from new and ongoing clinical trials at the 2013 American Urological Association (AUA) Annual Meeting from May 4-8, 2013 in San Diego, California.
"The PROVENGE research presented at this year's AUA Annual Meeting reflects Dendreon's ongoing commitment to men in need of new treatment options for advanced prostate cancer," said Mark Frohlich, M.D., executive vice president of research and development and chief medical officer at Dendreon. "Data from the pivotal Phase III IMPACT trial, the Phase II ProACT study and the Phase IV PROCEED registry provide the healthcare community with a better understanding of the role of PROVENGE in the metastatic castrate-resistant prostate cancer treatment continuum."
• Abstract #960: E. David Crawford, M.D., professor of surgery, urology, and radiation oncology, and head of the section of urologic oncology at the University of Colorado Denver School of Medicine, will present a poster titled "Optimal Timing for Treatment of Metastatic Castration-Resistant Prostate Cancer (mCRPC): Sequencing and Identifying Parameters of Early Progression with Sipuleucel-T:" In the Phase 3 IMPACT trial, a retrospective subgroup analysis suggested a greater PROVENGE treatment effect in those patients with a lower baseline PSA. These data were recently published in the international journal, Urology.
• Abstract #971: Thomas Gardner, M.D., associate professor in the Department of Microbiology and Immunology at Indiana University School of Medicine, will present a poster titled "Safety and Changes in Laboratory Parameters Associated with Sipuleucel-T in Patients with Metastatic Castration-Resistant Prostate Cancer: Phase II ProACT study:" A Phase II study evaluated immune responses and overall survival of patients receiving PROVENGE manufactured with different concentrations of antigen. Increased globulin protein and transient increased eosinophil counts were consistent with previous studies and positively correlated with immune response and overall survival. The safety profile of PROVENGE was consistent with that observed in previous clinical trials.
• Abstract #972: Matthew Cooperberg, M.D., assistant professor of urology, epidemiology and biostatistics, University of California, San Francisco, will present a poster titled "Treatment Practice Patterns in Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients Prior to Receiving Sipuleucel-T: Data from PROCEED:" In a Phase IV registry study, data on patients enrolled before they received PROVENGE provides a window into current treatment patterns for patients with advanced prostate cancer and will continue to yield important information that can be used to track trends in patient demographics and treatment prior to and after receiving PROVENGE.
"These presentations at AUA provide the medical community with possible new insight on the role of PROVENGE in men with advanced prostate cancer," said E. David Crawford, M.D., professor of surgery, urology, and radiation oncology, and head of the section of urologic oncology at the University of Colorado, Denver School of Medicine