Provectus Pharmaceuticals, Inc. Begins Phase 2 Clinical Trial For Psoriasis

Main Category: Eczema / Psoriasis
Also Included In: Clinical Trials / Drug Trials
Article Date: 14 Nov 2007 - 13:00 PDT

email to a friend   printer friendly   opinions  

Provectus Pharmaceuticals, Inc. (OTCBB: PVCT) has obtained approval to begin Phase 2 clinical testing of PH-10, the company's topical drug for dermatology, for the treatment of psoriasis. The study is designed to evaluate efficacy of PH-10 in a total of twenty-five subjects with moderate to severe forms of the disease.

In the study, PH-10 will be applied twice weekly for up to twelve weeks to each subject's psoriatic plaque areas. Response will be observed throughout this treatment phase, and for one month after the end of this period. Response will be graded using the Psoriasis Severity Index (PSI) and an investigator's clinical assessment of Plaque Response. Changes in pruritus (itching), time-to-response (TTR) and preliminary assessment of durability of response will also be assessed, along with comprehensive safety monitoring. The study will be conducted at the Mount Sinai School of Medicine in New York City. Further details of the study will be available in the near future on the clinical trial registry site, http://www.ClinicalTrials.gov.

"Building on the results from our Phase 1 program, which looked at safety and preliminary efficacy of several formulations of PH-10, we are pleased to begin this Phase 2 study in psoriasis," said Craig Dees, PhD, Chief Executive Officer of Provectus. "In addition to this study, we expect to soon begin clinical study of PH-10 for atopic dermatitis (eczema), and are continuing pre-clinical studies of PH-10 for treatment of infectious diseases of the skin, focused on antibiotic resistant Staphylococcus aureus (MRSA), which is a growing public health concern."

Dees continued: "Topical PH-10 may be advantageous in psoriasis, eczema, and other indications in dermatology that are largely underserved markets characterized by expensive products that often carry a number of extremely undesirable side-effects, including local or systemic infection and in some cases can result in cancer. We are optimistic that PH-10 can improve the opportunities available to a large number of these patients."

About Provectus Pharmaceuticals, Inc.

Provectus Pharmaceuticals specializes in developing oncology and dermatology therapies that are safer, more effective and less invasive than conventional therapies. Provectus is currently conducting clinical trials of their proprietary drugs PV-10 as a therapy for melanoma and breast cancer, and PH-10 as a topical treatment for severe psoriasis and eczema. The Company recently commenced Phase 2 clinical testing of PV-10 for melanoma and has received orphan drug designation from the FDA for melanoma. Additionally, the Company has begun Phase 2 clinical testing of its topical product PH-10 for psoriasis. Complementing their suite of proprietary drugs, Provectus has developed a number of intellectual properties and technologies in the areas of medical devices and biotechnology. For additional information about Provectus please visit the Company's website at http://www.pvct.com.

Forward-Looking Statements

The forward-looking statements contained herein are subject to certain risks and uncertainties that could cause actual results to differ materially from those reflected in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which reflect management's analysis only as of the date hereof. The Company undertakes no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date thereof.

Provectus Pharmaceuticals, Inc.

• Additional
• References
• Citations