KNOXVILLE, Tenn.--(BUSINESS WIRE)--Provectus Pharmaceuticals, Inc. (OTCBB: PVCT, http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company, has held its third end-of-Phase 2 meeting with the U.S. Food and Drug Administration (“FDA”). The meeting, held October 18, 2011, addressed several topics central to definition of the applicable patient population and primary endpoint for the Company's planned pivotal Phase 3 randomized controlled trial (“RCT”) of PV-10 for metastatic melanoma. Provectus is seeking consensus on design of the study that qualifies for Special Protocol Assessment (“SPA”) and supports approval of PV-10 for its melanoma indication.
Craig Dees, Ph.D., CEO of Provectus said, "This meeting was extremely productive in defining the threshold the FDA will require for approval in melanoma, which is a rapidly evolving therapeutic area. Based on the recommendations of senior FDA officials during this meeting, we have requested a fourth end-of-Phase 2 meeting to finalize our design with the new Division of Oncology Products 2 (“DOP2”), which takes over review responsibility of PV-10 for melanoma after an extensive reorganization of the FDA over the past few months. We expect this next meeting will provide the remaining groundwork to allow us to reach a consensus on a design suitable for SPA. The input of the FDA will be critical to designing a study to meet current and likely future standards for approval."
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. We are fortunate that our capital structure affords flexibility in optimizing our development plan to maximize likelihood of approval in the major melanoma markets in the U.S., Australia and the European Union."
Dr. Dees concluded, “At our recent meeting with the FDA, it was confirmed that lead review of our program for hepatocellular carcinoma (“HCC”), the most common form of primary liver cancer, will also reside within DOP2. This should benefit us as we prepare to commence Phase 2 testing of PV-10 for HCC since there will be potential regulatory synergy arising from the similar clinical features of both the HCC and melanoma programs.”
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.
FORWARD-LOOKING STATEMENTS: The forward-looking statements contained herein are subject to certain risks and uncertainties that could cause actual results to differ materially from those reflected in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which reflect management's analysis only as of the date hereof. The company undertakes no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date thereof.