Provectus Pharmaceuticals announced today that it has received approval to begin Phase 2 clinical testing of PH-10, the company’s topical drug designed to treat psoriasis. The study is intended to identify the effectiveness of PH-10 by using twenty-five subjects with moderate to severe forms of the disease.
PH-10 will be applied twice weekly for up to twelve weeks to each participant’s psoriatic plaque areas. The reaction will be monitored throughout this treatment phase and a month after the end of the phase. Response will be graded using the Psoriasis Severity Index (PSI) and an investigator’s clinical assessment of Plaque Response. Changes in itching, time-to-response, and preliminary assessment of durability of response will also be assessed, together with comprehensive safety monitoring.
Craig Dees, PhD, Chief Executive Officer of Provectus, stated, “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. 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.”
Dr. 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.”
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