Provectus Biopharmaceuticals to Meet with FDA on Operational Aspects of PV-10 Phase 3 Melanoma Study


Provectus Biopharmaceuticals, Inc. (NYSE MKT:PVCT,, a development-stage oncology and dermatology biopharmaceutical company (“Provectus”), announced today that it will be meeting with the U.S. Food and Drug Administration (the “FDA”) to review certain operational aspects of the protocol for its planned phase 3 clinical trial of intralesional PV-10, its novel investigational drug for cancer, as a treatment for melanoma. No date for this meeting has been agreed upon as yet.

Eric Wachter, PhD, CTO of Provectus, stated, “When we submitted the protocol to the Agency in November, we included a brief list of questions about certain operational aspects of the protocol, in particular regarding eligibility requirements relevant to maximizing the speed of enrollment of patients in the study. This is standard practice for a pivotal submission. The FDA has subsequently indicated that a formal meeting is appropriate to assure that these questions are addressed in a timely and documented manner. We hope the meeting will occur in January or early February 2015.”

Dr. Wachter added, “We currently have eight sites, four in the U.S. and four in Australia, in our expanded access program that are using PV-10 for melanoma and other cutaneous malignancies. They will provide a path to quickly starting enrollment once this review period is finished. In addition, we expect additional sites to join the study pending action by their respective Institutional Review Boards.”

Dr. Wachter concluded, “I want to stress that this meeting with the Agency in no way affects the fundamental design of the study, and the FDA has given us no indication that it has any concerns about the proposed study design and endpoints.”

For a detailed list of the current inclusion and exclusion criteria and further details regarding the endpoints of the study, visit:

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