Phase 3 protocol submitted for Provectus’ PV-10
KNOXVILLE, Tenn.—Provectus Biopharmaceuticals Inc. recently submitted its Phase 3 protocol for the evaluation of PV-10 for the treatment of locally advanced cutaneous melanoma to the U.S. Food and Drug Administration (FDA). It is expected that the FDA will review the submission and provide its comments within 30 to 45 days. According to a July 8 letter to shareholders from Dr. Craig Dees, CEO of Provectus, “The primary endpoint of the study is progression-free survival assessed using standard RECIST 1.1 criteria. Secondary endpoints are complete response rate and overall survival. Progression- free survival and overall survival are standard endpoints for oncology approvals.” PV-10 is a novel investigational cancer drug designed for injection into solid tumors, with a focus on melanoma, breast cancer and cancers of the liver. The FDA has granted orphan drug designations for PV-10 for the melanoma and hepatocellular carcinoma indications.