Provectus Pharmaceuticals Completes Patient Accrual In Initial Phase 2 Study Of PH-10 For Atopic Dermatitis

Main Category: Dermatology
Also Included In: Clinical Trials / Drug Trials
Article Date: 02 Jul 2009 - 7:00 PDT

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Provectus Pharmaceuticals, Inc. (OTC BB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, has completed patient accrual for its Phase 2 study of PH-10 for atopic dermatitis. PH-10 is the Company's topical drug for the treatment of dermatologic diseases, including atopic dermatitis, a chronic skin condition that includes some forms of eczema. The Phase 2 study was designed to evaluate safety and efficacy of PH-10 in at least twenty subjects with mild to severe forms of the disease.

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. Response was graded using the Investigator's Global Assessment (IGA) and Eczema Area Severity Index (EASI) assessment. Changes in pruritus (itching) were also assessed, along with comprehensive safety monitoring.

Dr. Craig Dees, Ph.D., CEO of Provectus said, "Very preliminary analysis of efficacy data from the first 5 subjects to complete the study showed that all experienced improvement, while safety data from the first fourteen subjects showed the treatment to be well tolerated. Although it will be several months before data from all study subjects is collected and analyzed, these initial results are extremely encouraging."

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.

Dr. Dees continued, "Having reached this milestone for atopic dermatitis, our next steps are to either seek a licensing partner for PH-10, or partner with a pharmaceutical dermatology concern to co-develop the product. We have begun preliminary discussions with interested parties and our intent is to continue to pursue a relationship that will benefit the company and our shareholders."

Source
Provectus Pharmaceuticals, Inc.