Dec 14 2010
Provectus Pharmaceuticals, Inc. (OTC BB: PVCT, http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company, has initiated a Phase 2c clinical trial of PH-10 for psoriasis. This multicenter, randomized controlled Phase 2c study is expected to enroll up to 90 subjects at four different sites, beginning in late December. The subjects will be randomized sequentially by center to one of four treatment cohorts, and will assess efficacy and safety of topical PH-10 applied once daily to areas of mild to moderate plaque psoriasis.
The Phase 2c trial will be conducted at four sites in the U.S. including the 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. With 90 subjects, this trial is the largest dermatological trial that Provectus has conducted to date.
Dr. Craig Dees, Ph.D., CEO of Provectus, said, "The results of this study are expected to define the parameters necessary for the design of a pivotal Phase 3 trial, and will be an important milestone on the regulatory pathway leading towards commercialization. In addition, we've held discussions with a number of potential outlicensing partners, and we believe this Phase 2c trial will further solidify the commercial viability of PH-10 in these discussions."
According to the National Institutes of Health, as many as 7.5 million Americans, approximately 2.2 percent of the U.S. 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.
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