Provectus Pharmaceuticals Inc. is quickly gaining a reputation as an up-and-coming development-stage oncology and dermatology biopharmaceutical company. Helping to enhance this reputation and its position in the marketplace, Provectus announced the addition of Mount Sinai School of Medicine as the second and final site for its expanded Phase 2 clinical trial of the company’s lead dermatology agent PH-10 for psoriasis. Jason Elmer, M.D., who served as the lead investigator for the Phase 2 clinical trial of PH-10 for atopic dermatitis of which patent enrollment was completed in June, will also serve as the principal investigator of this trial.
Commenting on the value of Dr. Elmer’s work on this project, Provectus CEO Craig Dees, Ph.D. stated, “Dr. Emer’s work with PH-10 for atopic dermatitis, his involvement in the ongoing research of the product as a dermatological therapy, and Mount Sinai School of Medicine’s outstanding reputation in dermatological research make this center an outstanding choice for the second and final site of our ongoing Phase 2 trial for psoriasis.”
Enrollment in the Phase 2 trial for psoriasis in expected to consist of 30 subjects and commenced in July of this year. Enrollment is non-randomized with the purpose of measuring safety and efficiency of 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. The estimated primary completion date for final data collection is February 2010, with the study estimated to be completed by April 2010. Patients interested in participating in the trial may find further information at the NIH clinical trials registry, www.clinicaltrials.gov or at www.pvct.com.
Statistics show there is a major need for this new development. 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.
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