Provectus Pharmaceuticals, Inc. (OTCBB: PVCT) (http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company, reports that the Moffitt Cancer Center has initiated a Phase 1 study to investigate potential immune biomarkers in both tumor tissue and peripheral blood after intralesional ("IL") PV-10 injection of melanoma tumors.
Amod Sarnaik, M.D. member of the Experimental Therapeutics Program at Moffitt and faculty member at the University of South Florida, is the principal investigator for the study, which is expected to enroll up to 15 subjects. Sarnaik said, "We look forward to verifying the promising pre-clinical data from our ongoing work in this translational study. These results should help elucidate the immunologic basis of the 'bystander effect' noted in previous clinical studies of PV-10 and help optimize PV-10 treatment, particularly in combination with other therapies. As Moffitt pursues its mission of contributing to the prevention and cure of cancer, we are pleased to spearhead this important clinical work."
Craig Dees, Ph.D., CEO of Provectus said, "We are delighted that Moffitt has initiated this clinical trial. We believe that the mechanism by which PV-10 can cause regression of un-injected lesions is novel. Although this study is separate from our expected registration pathway (study of PV-10 in melanoma patients with locoregional disease accessible to PV-10 treatment), this work is very important as it will help us to better understand the potential systemic benefit of PV-10 treatment, and suggest logical therapeutic combinations that may augment the apparent immune response to PV-10 treatment in cancer patients with substantial tumor burden.
Provectus Pharmaceuticals, Inc.