Heading down the path in search of a Special Protocol Assessment (SPA) from the Food and Drug Administration, Provectus Pharmaceuticals (OTCBB:PVCT), a biotech specialized in developing oncology and dermatology therapies, has received guidance from the FDA to submit its Phase 3 protocol for review.  After several meetings with the agency, Provectus had originally requested a final end-of-Phase 2 meeting with the FDA, which the FDA said was not necessary.

Provectus is moving into the pivotal third phase of clinical trials with PV-10 for metastatic melanoma.  A SPA represents an agreement from the FDA that the Phase 3 study design endpoints, statistical analyses and other components of the planned clinical trials are acceptable to support approval of the product.

“[We] believe that significant progress had been achieved in defining the threshold the FDA will require for approval in melanoma, which is a rapidly evolving therapeutic area,” said Provectus CEO Dr. Craig Dees.  He added, “Using recommendations of senior FDA officials from that meeting, including those related to patient population and primary endpoint, we intend to request SPA review of our protocol, which we expect will be submitted before the end of the first quarter.”

Yesterday, the company said that it will be presenting nonclinical data on the immunologic mechanism of action of PV-10 at the Society of Surgical Oncology Annual Meeting, March 21-24, 2012, at the Orlando World Center Marriott in Orlando, Florida. The data, by Dr. Paul Toomey and colleagues of the H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, will be presented in an abstract titled “Intralesional Injection of Melanoma with Rose Bengal Induces Regression of Untreated Synchronous Melanoma in a Murine Model” during the melanoma poster session.

Provectus Pharmaceuticals (PVCT) Stock Quote and News:

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