May 24 2011
Provectus Pharmaceuticals, Inc. (OTC BB: PVCT, http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company, has completed patient accrual in its Phase 2C clinical trial of PH-10 for the treatment of psoriasis. PH-10, an aqueous hydrogel formulation of Rose Bengal disodium for topical administration to the skin, is being studied for the treatment of cutaneous skin disorders, specifically psoriasis and atopic dermatitis.
“We expect the results of this clinical trial will help define the commercial viability of PH-10 for psoriasis, and will be an integral part of discussions that we are having with potential out-licensing partners.”
Craig Dees, Ph.D., CEO of Provectus said, "We expect the results of this clinical trial will help define the commercial viability of PH-10 for psoriasis, and will be an integral part of discussions that we are having with potential out-licensing partners."
The multi-center, randomized, vehicle controlled Phase 2C trial has enrolled more than 90 subjects at four different sites, and represents the largest dermatological study that Provectus has conducted to date. The subjects have been randomized sequentially by center to one of four treatment cohorts, in order to assess efficacy and safety of topical PH-10 applied once daily to areas of mild to moderate plaque psoriasis. The four clinical trial sites include Mount Sinai School of Medicine in New York City, Wake Research Associates in Raleigh, NC, Dermatology Specialists in Oceanside, CA and International Dermatology Research in Miami, FL. Final subject assessment is scheduled to be completed in eight weeks.
According to the National Institutes of Health, as many as 7.5 million Americans, approximately 2.2 percent of the population, have psoriasis. The National Psoriasis Foundation reports that approximately 125 million people worldwide, 2 to 3 percent of the total population, have psoriasis. It also reports that total direct and indirect health care costs of psoriasis for patients are approximately $11.25 billion annually.
SOURCE Provectus Pharmaceuticals, Inc.