Provectus Pharmaceuticals Announces H. Lee Moffitt Cancer Center Initiates Phase 1 Study Of PV-10 To Elucidate Bystander Effect
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.
About Moffitt Cancer CenterLocated in Tampa, Moffitt is one of only 41 National Cancer Institute-designated Comprehensive Cancer Centers , a distinction that recognizes Moffitt’s excellence in research, its contributions to clinical trials, prevention and cancer control. Since 1999, Moffitt has been listed in U.S. News & World Report as one of “America’s Best Hospitals” for cancer. With more than 4,200 employees, Moffitt has an economic impact on the state of nearly $2 billion. For more information, visit MOFFITT.org , and follow the Moffitt momentum on Facebook , twitter and YouTube . About Provectus Pharmaceuticals, Inc. Provectus Pharmaceuticals specializes in developing oncology and dermatology therapies. Its novel oncology drug PV-10 is designed to selectively target and destroy cancer cells without harming surrounding healthy tissue, significantly reducing potential for systemic side effects. Its oncology focus is on melanoma, breast cancer and cancers of the liver. The Company has received orphan drug designations from the FDA for its melanoma and hepatocellular carcinoma indications. Its dermatological drug PH-10 also targets abnormal or diseased cells, with the current focus on psoriasis and atopic dermatitis. Provectus has recently completed Phase 2 trials of PV-10 as a therapy for metastatic melanoma, and of PH-10 as a topical treatment for atopic dermatitis and psoriasis. Information about these and the Company's other clinical trials can be found at the NIH registry, www.clinicaltrials.gov. For additional information about Provectus please visit the Company's website at www.pvct.com or contact Porter, LeVay & Rose, Inc. FORWARD-LOOKING STATEMENTS: The forward-looking statements contained herein are subject to certain risks and uncertainties that could cause actual results to differ materially from those reflected in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which reflect management's analysis only as of the date hereof. The company undertakes no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date thereof.
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