KNOXVILLE, Tenn.–(BUSINESS WIRE)–Provectus Pharmaceuticals, Inc. (OTCBB: PVCT, http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company, has received guidance from the U.S. Food and Drug Administration (“FDA”) to submit its Phase 3 protocol for review, either via standard review or a request for Special Protocol Assessment (“SPA”). This guidance was in response to Provectus’s request of a final end-of-Phase 2 meeting to achieve consensus on design of a planned pivotal Phase 3 randomized controlled trial (“RCT”) of PV-10 for metastatic melanoma. The FDA indicated that an additional end-of-Phase 2 meeting with Provectus is not required.
Click below to hear audio interview with Dr. Craig Dees, CEO of Provectus.
Provectus is seeking consensus on a design that will qualify for Special Protocol Assessment and supports approval of PV-10 for its melanoma indication. The Company intends to pursue the SPA path, which would represent 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.
Craig Dees, Ph.D., 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.”
Dr. Dees continued, “We also continue to assess whether a second Phase 3 RCT, tailored to meet the regulatory requirements of Australia, would be helpful in accelerating approval in that important market, and whether emerging results from ongoing immunologic mechanism of action studies can be used to support accelerated approval in the U.S. We are fortunate to have the necessary resources to allow sufficient flexibility in our development plan to maximize likelihood of approval in the major melanoma markets in the U.S., Australia and the European Union.”
More information about the Special Protocol Assessment is contained in the Appendix to this press release.
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.