Provectus Pharmaceuticals, Inc., a development-stage biopharma specialist creating innovative new therapies for the oncology (focused on melanoma) and dermatology markets, whose leading oncology agent, PV-10, is engineered to precisely target cancer cells without harming surrounding tissues while delimiting negative side effects, announced the holding of an end-of-Phase 2 meeting with the FDA regarding licensure endpoints and the potential clinical program scope of the Company’s metastatic melanoma formulation PV-10.
Held at White Oak Campus, the FDA’s site in Silver Spring, MD, with the essential goal of creating consensus relevant to extant clinical data as to how to proceed, the meeting offered an opportunity to vet the clinical applications of PV-10, which is a proprietary, injectable formulation of a 30-year old compound called Rose Bengal, used by ophthalmologists to evaluate damage to the eye.
CEO of PVCT, Craig Dees, Ph.D., was pleased to have this valuable opportunity to go over the data amassed thus far from Phase 1 and 2 studies with PV-10, and characterized the meeting as bearing fruitful results as per “definition of the pathway leading to licensure”.
Dr. Dees acknowledged the need for a second end-of-Phase 2 meeting in the months ahead, after having consulted with FDA officials, because the crucial Phase 3 randomized controlled study design must be both perfect and in accordance with requirements in order to qualify for Special Protocol Assessment (SPA).
Dr. Dees noted that the Company was indeed fortunate to be able to afford the kind of flexibility which allows them to consider either the conventional Phase 3 or an accelerated route to licensure. That is, while the Company considers Phase 3 SPA a rock-solid standard, considering the nature of the disease and data generated thus far on PV-10, the opportunity to achieve accelerated approval may also be advantageous.
Rose Bengal is a small molecule with a three-decade track record of proven safety, a short half-life in the blood, and the ability to be easily excreted by the liver and kidneys without inordinate strain to these organs. It was first selected by the Company when the substance was observed to have the capacity to selectively target cancer cells via chemoablation, killing them in a way that mimics both apoptosis and necrosis.
The Company has received FDA orphan drug designation for its leading melanoma indication, and is proceeding in Phase 2 trialing of PH-10, their leading dermatological topical treatment for atopic dermatitis and psoriasis, and has recently initiated Phase 1 of PV-10 for liver cancer.