Melanoma Treatment-End of Phase 2
Provectus Reports on Successful End-of-Phase 2 Meeting with U. S. FDA and Gains Clarity for Licensure of PV-10 Metastatic Melanoma
St. Luke's Melanoma Expert Sanjiv Agarwala, MD, Served as the Trial's Phase 2 Principal Investigator in Bethlehem, PA
Bethlehem, PA 4/30/2010) - Provectus Pharmaceuticals, Inc. (OTCBB: PVCT, pvct.com), a development-stage oncology and dermatology biopharmaceutical company, announced that it has held an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to seek consensus on clinical program scope and endpoints for licensure of PV-10 for metastatic melanoma. The meeting was held at the Agency's White Oak Campus in Silver Spring, MD.
Internationally recognized melanoma investigator Sanjiv Agarwala, MD of St. Luke's Cancer Center served as the principal investigator for Phase II of the trial in Bethlehem, Pennsylvania. “St. Luke's Cancer Center is excited to be a part of the ongoing research in this interesting drug for this devastating disease,” says Dr. Agarwala. “There are very few options for patients with advanced melanoma and currently-available therapies are not that effective. Any new possibility is worth investigating.”
Craig Dees, PhD, CEO of Provectus said, “This meeting provided an opportunity to thoroughly review the clinical data we have amassed through our Phase 1 and Phase 2 studies with PV-10. As expected, the meeting was fruitful and provided a forum for discussion of appropriate endpoints for assessment of clinical benefit of PV-10 in melanoma patients and for definition of the pathway leading to licensure.”
Dr. Dees continued, “Based on consultation with senior Agency officials during this meeting, we expect to hold a second end-of-Phase 2 meeting in the coming months to finalize design of a pivotal Phase 3 randomized controlled study suitable for Special Protocol Assessment (SPA).”
Dr. Dees concluded, “We are fortunate that our capital resources afford flexibility to consider pursuing both the conventional Phase 3 pathway, as well as an accelerated route to licensure. While we believe the Phase 3 with an SPA represents an industry standard path to approval, we believe the door may still be open for accelerated approval.”
PV-10 is a proprietary, injectable formulation of Rose Bengal, a compound that has been in use for nearly thirty years by ophthalmologists to assess damage to the eye. It has also been used as an intravenous diagnostic to detect ailments of the liver. Rose Bengal is a small molecule agent with an established safety history, a short half-life in the bloodstream, and is excreted via the liver and kidneys. Provectus has discovered a novel use for Rose Bengal based on the observation that it is selectively toxic to cancer calls via a process called chemoablation whereby cells undergo a form of cell death that mimics both features of necrosis and apoptosis.