Provectus Reaches Milestone With Completion Of Patient Accrual In Phase 2 Trial Of PH-10 For Psoriasis

Main Category: Eczema / Psoriasis
Also Included In: Dermatology;  Clinical Trials / Drug Trials
Article Date: 15 Oct 2009 - 1:00 PDT

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Provectus Pharmaceuticals, Inc. (OTC BB: PVCT), a development stage oncology and dermatology biopharmaceutical company, has completed patient accrual and initial treatment in its Phase 2 trial of PH-10 for the treatment of plaque psoriasis. This milestone marks the third Phase 2 clinical trial for which Provectus has completed patient accrual since May 2009.

The study involves treatment of 30 subjects with mild-to-moderate plaque psoriasis on the trunk or extremities to investigate the efficacy and safety of topical PH-10 applied once daily to the plaque areas. Primary outcome measures include "Treatment Success", a static endpoint assessed at Day 29 after initial PH-10 treatment and defined as 0 or 1 on all Psoriasis Severity Index (PSI) components and 0 or 1 on the Plaque Response scale. The primary safety endpoint is incidence of adverse experiences, including pain and dermatologic/skin toxicity. The study began in July 2009 and is estimated to be completed by December 2009, with final data collection for primary outcome estimated to be February 2010.

Dr. Craig Dees, Ph.D., CEO of Provectus said, "As a topical gel, PH-10 offers many potential advantages over available treatments for psoriasis. In particular, because it is applied onto the skin, it works directly on the psoriasis, without the likelihood of producing adverse systemic side effects that characterize many other therapies. With all patients now enrolled, we look forward to the completion of this trial."

He concluded, "The completion of patient accrual for this trial marks the third trial for which we have completed patient accrual within the past five months. I believe this demonstrates the level of commitment our company has to developing our product pipeline of drugs, PV-10 and PH-10, and bringing to market drugs that are efficacious and safe for our target oncological and dermatological indications."

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.

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.