Provectus Announces Preliminary Phase 2 Data For PH-10 In Its Psoriasis And Atopic Dermatitis Trials

Main Category: Eczema / Psoriasis
Also Included In: Dermatology;  Clinical Trials / Drug Trials
Article Date: 02 Dec 2009 - 20:00 PDT

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Provectus Pharmaceuticals, Inc. (OTC BB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, announced preliminary data for the company's PH-10 Phase 2 clinical trial for Psoriasis as well as for its Phase 2 clinical trial for Atopic Dermatitis.

Dr. Craig Dees, Ph.D., CEO of Provectus said, "We are excited by the positive data reported from both of the Phase 2 clinical trials for PH-10. As previously announced, our development plans include seeking licensure of PH-10 for the treatment of serious dermatological diseases. Based upon these initial results, we are ramping up these efforts, and are actively seeking to engage a financial advisor to assist us with a proposed licensing transaction."

In its Phase 2 trial of PH-10 for psoriasis, preliminary data shows that 79% of 29 subjects in the clinical trial demonstrated improvement in the Psoriasis Scoring Index (PSI) during four weeks of daily treatment with PH-10. In addition, 83% of the subjects reported no or only mild pruritus (itching) by week four of the trial, with no significant safety issues noted. The 30th and final subject will complete final evaluation in early December.

The study, which involves treatment of 30 subjects with mild-to-moderate plaque psoriasis on the trunk or extremities, was designed to assess the efficacy and safety of topical PH-10 applied once daily to psoriatic plaque areas. The study began in July 2009 and is expected to be completed by December 2009, with final data collection for primary outcome by February 2010.

In its Phase 2 trial of PH-10 for atopic dermatitis ("eczema"), preliminary data from the first 18 subjects indicated that 94% of subjects had improvement in the Eczema Area Severity Index (EASI) during four weeks of treatment. Subjects applied PH-10 daily for up to four weeks to skin areas affected by atopic dermatitis, with response observed weekly throughout this treatment phase and for one month after the end of this period. As in the psoriasis study, the treatments were generally well tolerated with no significant safety issues identified.

Dees noted, "These data are consistent with earlier observations from Phase 1 testing of PH-10 for psoriasis. The potential efficacy, combined with the low incidence of side effects, is very encouraging."

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.

The National Eczema Association estimates that atopic dermatitis affects more than 30 million Americans. Atopic dermatitis causes itchy, inflamed skin, and usually begins in childhood, often during infancy. While symptoms often fade during childhood, many patients have atopic dermatitis throughout their lives.

About 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. Rose Bengal is a compound that has been in use for nearly thirty years by ophthalmologists to assess damage to the eye and has an established safety history. It has also been used as an intravenous diagnostic to detect ailments of the liver.

Source
Provectus Pharmaceuticals, Inc.

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