Provectus Pharmaceuticals Completes Patient Accrual in Initial Phase 2 Study of PH-10 for Atopic Dermatitis

Wednesday, 01 July 2009 05:46

KNOXVILLE, Tenn.--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.”

About Provectus Pharmaceuticals, Inc. (www.pvct.com)

Provectus Pharmaceuticals is a development stage company that specializes in oncology and dermatology therapies that are safer, more effective, less invasive and more economical than conventional therapies. Provectus is currently conducting Phase 2 clinical trials of their proprietary drugs PV-10 as a therapy for metastatic melanoma and PH-10 as a topical treatment for psoriasis and atopic dermatitis. Information about the Company's clinical trials can be found at the NIH registry, www.clinicaltrials.gov. The Company has received orphan drug designation from the FDA for its melanoma indication. Complementing their suite of proprietary drugs, Provectus has developed a number of intellectual properties and technologies in the areas of imaging, medical devices and biotechnology. For additional information about Provectus please visit the Company's website at www.pvct.com or contact Porter, LeVay & Rose, Inc.

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