Provectus Pharmaceuticals Initiates New PH-10 Clinical Study For Psoriasis
Provectus Pharmaceuticals, Inc. (OTC BB: PVCT ), a development-stage oncology and dermatology biopharmaceutical company, has initiated a new Phase 2 clinical trial of PH-10 for psoriasis involving daily dosing of patients for 28 days. After reviewing safety and efficacy data from its PH-10 trial for atopic dermatitis, Provectus determined that daily dosing of patients with psoriasis trial would be an appropriate and attractive regimen. The new study supplants an earlier Phase 2 study, using twice weekly dosing for 12 weeks, which was terminated earlier in June.
Preliminary analysis of the data from the first six psoriasis patients to complete the earlier Phase 2 study showed that repeat treatment with PH-10 was safe, with evidence of efficacy noted in some subjects. This analysis, combined with the data obtained from the on-going atopic dermatitis study, indicated that increased dosing frequency was appropriate for psoriasis. The new protocol replaces twice weekly application of PH-10 with daily application.
Enrollment in the new trial has commenced and the first patients have begun active participation at the first clinical site in Miami, FL. Patients interested in participating in the trial may find further information at the NIH clinical trials registry, www.clinicaltrials.gov or at http://www.pvct.com.
Craig Dees, Ph.D., CEO of Provectus said, "PH-10 differs from most other advanced therapies for chronic skin conditions, like atopic dermatitis and psoriasis, because it's topically applied, confining effects to diseased skin. This approach can improve efficacy and largely eliminates any potential for systemic side effects that have accompanied many recent systemic therapies."
Dees concluded, "With this improved protocol that we believe will support robust data in a second dermatology indication, we have reached the point in the development of PH-10 where we are ready for either a licensing or co-development partnership. Therefore, part of our efforts in the months ahead will involve exploring these possibilities with major parties in the dermatology sector, while simultaneously continuing our clinical trials."
According to the National Institutes of Health, as many as 7.5 million Americans, approximately 2.2 percent of the 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.
Provectus Pharmaceuticals, Inc.