Mount Sinai School Of Medicine Added As Second Site For Provectus Pharmaceuticals' Phase 2 Clinical Study Of PH-10 For Psoriasis

Main Category: Eczema / Psoriasis
Also Included In: Clinical Trials / Drug Trials;  Dermatology
Article Date: 20 Aug 2009 - 1:00 PDT

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Provectus Pharmaceuticals, Inc. (OTCBB:PVCT), a development-stage oncology and dermatology biopharmaceutical company, has added Mount Sinai School of Medicine as its second and final site for its expanded Phase 2 clinical trial of the Company's lead dermatology agent PH-10 for psoriasis. Jason Emer, M.D. will serve as principal investigator of the trial; he is also the lead investigator for the Phase 2 clinical trial of PH-10 for atopic dermatitis, for which patient enrollment was completed in June.

Craig Dees, Ph.D., CEO of Provectus said, "Dr. Emer's work with PH-10 for atopic dermatitis, his involvement in the ongoing research of the product as a dermatological therapy, and Mount Sinai School of Medicine's outstanding reputation in dermatological research make this center an outstanding choice for the second and final site of our ongoing Phase 2 trial for psoriasis."

Enrollment in the Phase 2 trial for psoriasis commenced in July 2009, and has an expected enrollment of 30 subjects. It is a non-randomized, open label, single group assignment trial that is designed to measure safety and efficacy of PH-10. PH-10 is an aqueous hydrogel formulation of rose bengal disodium for topical administration to the skin, and is being studied for the treatment of cutaneous skin disorders, specifically psoriasis and atopic dermatitis. The estimated primary completion date for final data collection is February 2010, with the study estimated to be completed by April 2010. Patients interested in participating in the trial may find further information at the NIH clinical trials registry, http://www.clinicaltrials.gov or at http://www.pvct.com.

Craig Dees, Ph.D., CEO of Provectus added, "The addition of this second site at Mount Sinai School of Medicine supports our developmental efforts for PH-10 which include either a licensing agreement or co-development partnership for our dermatological treatments. We are continuing to explore these possibilities with major parties in the dermatology sector as this trial proceeds towards completion."

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.