In August, Provectus Pharmaceuticals released the results of two presentations about their drug in development for metastatic melanoma, PV-10, detailing the Phase II trial design and results. Now, Provectus Pharmaceuticals announced that the FDA has provided them with guidance about submitting its Phase III protocol for review.

The Phase III review will be conducted through either standard review or with a request for a Special Protocol Assessment (SPA). The guidance from the FDA came in response to Provectus’s request for a last end-of-Phase II meeting, during which consensus on the design of the Phase III trial was to be achieved. The FDA did not require a final meeting with Provectus, the company reports, for the Phase III randomized controlled trial.

According to a press release from Provectus, the SPA review design will be pursued. Such a review would represent an agreement between Provectus and the FDA “that the Phase III study design endpoints, statistical analyses and other components of the planned clinical trials are acceptable to support approval of the product.”

Craig Dees, PhD, CEO of Provectus said, "Following our third meeting with the Agency in October, we believed 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. 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. While SPA can occur over as little as 45 calendar days, it is important to note that this is frequently an iterative process, and could take longer as we work with the Agency to reach ultimate agreement on study design."

PV-10, the drug for metastatic melanoma under review, “is designed to selectively target and destroy cancer cells without harming surrounding healthy tissue, significantly reducing potential for systemic side effects,” according to Provectus.

For more information about PV-10, and to learn more about the SPA, please click here.