Provectus Announces Top Line Phase 2 Data For PH-10 in Its First Randomized Controlled Psoriasis Study
-- Data Corroborates Potential Effectiveness in Mild to Moderate Plaque Psoriasis --
-- Milestone Has Increased Efforts to Seek Licensure of PH-10 for Treatment of Serious Dermatological Diseases –
KNOXVILLE, Tenn.--(BUSINESS WIRE)--Mar 19, 2012 - Provectus Pharmaceuticals, Inc. (OTCBB:PVCT,http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company, announced top-line data for the company's randomized controlled trial (RCT) of PH-10 for mild-to-moderate plaque psoriasis.
The Phase 2 trial (protocol PH-10-PS-23) compared safety and efficacy of three dose levels of PH-10 (0.002% Rose Bengal, 0.005% Rose Bengal and 0.01% Rose Bengal) against vehicle. Ninety-nine subjects with mild-to-moderate plaque psoriasis of the trunk and/or extremities were randomized to one of the four study arms and applied their assigned test article once daily for 28 consecutive days. Subjects were assessed weekly during the treatment interval, and returned one week and four weeks after their final application for final assessment of safety and efficacy. Efficacy was assessed using the Psoriasis Severity Index (PSI), the Plaque Response Assessment scale, and the Pruritus (itching) Self Assessment scale. Similarity of the patient population, study events schedule and study assessments allows results from the randomized trial to be compared side-by-side with those of a prior single-arm trial of PH-10 using a lower dose level (protocol PH-10-PS-22, which used PH-10 at 0.001% Rose Bengal). The study began in December 2010 and was completed in August 2011, with final data collection for primary outcome completed in February 2012.
Results for all three efficacy parameters showed improvement in psoriasis symptoms over the treatment interval, with the low dose of PH-10 (0.002%) providing uniformly consistent improvement, while reduced therapeutic activity was observed at the two higher doses. Response for PH-10 at 0.002% Rose Bengal was comparable to that observed previously using PH-10 at 0.001% Rose Bengal. After 28 days of treatment with PH-10 (all strengths), 23-29% of subjects achieved complete or nearly complete resolution of all PSI component symptoms (erythema, induration and desquamation), compared to no subjects in the vehicle arm. Thirty eight percent of subjects receiving the low dose of PH-10 reported no itching after 28 days compared with 14% of those receiving vehicle (45% of subjects receiving 0.001% Rose Bengal in the earlier study reported no itching after 28 days). PH-10 at 0.002% and 0.005% (along with 0.001% in the prior study) exhibited maximum improvement in Plaque Response Assessment, with the improvements for 0.002% achieving high significance (p < 0.001) after two weeks of treatment; all strengths proved superior to vehicle after 28 days, with the highest strength exhibiting the least activity. As noted in prior studies, PH-10 was generally well tolerated with only transient mild to occasionally moderate adverse experiences limited to the application site.
Dr. Craig Dees, Ph.D., CEO of Provectus said, "We are excited by the positive data reported for this randomized trial of PH-10. Despite the complexity of this four-arm study, we are pleased that it clearly showed that the low dose level was optimal of the three doses tested, with similar activity to that seen in our earlier single-arm trial, and that it was superior to vehicle. These important results provide us with powerful data to guide us as we ramp up our development efforts. We expect the data from this randomized study will eventually lead to a term sheet for a proposed licensing agreement which will trigger the engagement of a financial advisor to assist us with that transaction."
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.
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. Rose Bengal is a compound that has been in use for over thirty years by ophthalmologists to assess damage to the eye and has an established safety history. It has also been used as an intravenous diagnostic to detect ailments of the liver.
About Provectus Pharmaceuticals, Inc.
Provectus Pharmaceuticals specializes in developing oncology and dermatology therapies. Its novel oncology drug PV-10 is designed to selectively target and destroy cancer cells without harming surrounding healthy tissue, significantly reducing potential for systemic side effects. Its oncology focus is on melanoma, breast cancer and cancers of the liver. The Company has received orphan drug designations from the FDA for its melanoma and hepatocellular carcinoma indications. Its dermatological drug PH-10 also targets abnormal or diseased cells, with the current focus on psoriasis and atopic dermatitis. Provectus has recently completed Phase 2 trials of PV-10 as a therapy for metastatic melanoma, and of PH-10 as a topical treatment for atopic dermatitis and psoriasis. Information about these and the Company's other clinical trials can be found at the NIH registry, www.clinicaltrials.gov. For additional information about Provectus please visit the Company's website at www.pvct.com or contact Porter, LeVay & Rose, Inc.
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.
Contact: Provectus Pharmaceuticals, Inc.
Peter R. Culpepper, 866-594-5999 #30
Porter, LeVay & Rose, Inc.
Marlon Nurse, DM, VP – Investor Relations
Bill Gordon, SVP – Media Relations
Posted: March 2012