Provectus Pharmaceuticals, Inc. (OTC BB: PVCT, http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company, announced that data and study design features on PV-10 for metastatic melanoma were presented at two separate conferences.
Data was presented by two of Provectus's Principal Investigators for the Phase 2 melanoma study, Dr. Sanjiv Agarwala, M.D., Chief of Medical Oncology and Hematology at St. Luke's Hospital and Health Network in Bethlehem, PA, and by Professor Merrick Ross, M.D., of the MD Anderson Cancer Center in Houston, Texas. Dr. Agarwala delivered a presentation entitled "Chemoablation of Metastatic Melanoma with Intralesional PV-10," at the 7th EADO (European Association of Dermato-Oncology) Conference in Nantes, France, and Dr. Ross's presentation was entitled "Intralesional Therapy for Systemic Disease: Implications for Success and Failure," at the HemOnc Today Conference in New York City.
In his presentation, Dr. Agarwala reviewed Phase 2 data on PV-10 and outlined primary design parameters for the Company's anticipated Phase 3 randomized controlled trial of PV-10, noting that the design is based on guidance obtained in meetings with the U.S. Food and Drug Administration (FDA) and the Australian Therapeutic Goods Administration (TGA). Dr. Agarwala's presentation may be viewed at: http://www.pvct.com/publications/Chemoablation_of_MM_with_PV-10-EADO-2011.pdf
"This was the first time that Phase 2 data and a Phase 3 design outline were widely disseminated to an audience of prospective European investigators who specialize in dermato-oncology and have special interest in injectable therapies," noted Dr. Agarwala. "I was truly impressed at the level of interest among this important group, some of whom will presumably play a key role in Phase 3, alongside investigators in the U.S. and Australia."
Dr. Ross provided a comprehensive review of intralesional therapies, starting with BCG (Bacillus Calmette-Guérin) and IL-2 (Interleukin-2) as antecedents to several promising modern intralesional therapies, including PV-10, that are currently undergoing advanced clinical testing. His presentation focused on the role of intralesional therapies for control of both local disease and their possible effect on systemic disease, such as that shown in Phase 2 testing of PV-10.
Dr. Craig Dees, PhD, CEO of Provectus said, "These presentations reinforce the role that PV-10 can play in the management of melanoma, particularly in the large population of patients with locoregional metastatic disease. As we prepare our multi-center, global Phase 3 trial, we take further encouragement from the positive reception of PV-10 in these diverse venues as evidence that the investigational therapy ultimately will be well received by the melanoma community."
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