Multi-Center Randomized Trial Includes More Than 90 Subjects
KNOXVILLE, Tenn.--(BUSINESS WIRE)-- 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.
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.
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 metastatic cancers of the liver. The Company has received orphan drug designation 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.
Provectus Pharmaceuticals, Inc.
Peter R. Culpepper, CFO
Porter, LeVay & Rose, Inc.
Marlon Nurse, DM, VP – Investor Relations
Bill Gordon, SVP – Media Relations
KEYWORDS: United States North America Tennessee
INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Pharmaceutical Research Science