Provectus Reaches Milestone with Completion of Patient Accrual in Phase 2 Trial of PH-10 for Psoriasis
Tuesday October 13, 2009
-- Third Phase 2 Completion of Patient Enrollment in Past Five Months --
KNOXVILLE, Tenn.--(BUSINESS WIRE)--Provectus Pharmaceuticals, Inc. (OTCBB:
PVCT,
http://www.pvct.com),
a development-stage oncology and dermatology biopharmaceutical company,
has completed patient accrual and initial treatment in its Phase 2 trial of PH-10 for the treatment of plaque psoriasis. This milestone marks the third
Phase 2 clinical trial for which Provectus has completed patient accrual since May 2009.
The study involves treatment of 30 subjects with mild-to-moderate plaque psoriasis on the trunk or extremities to investigate the efficacy and safety of
topical PH-10 applied once daily to the plaque areas. Primary outcome measures include "Treatment Success", a static endpoint assessed at Day 29
after initial PH-10 treatment and defined as 0 or 1 on all Psoriasis Severity Index (PSI) components and 0 or 1 on the Plaque Response scale.
The primary safety endpoint is incidence of adverse experiences, including pain and dermatologic/skin toxicity. The study began in July 2009 and is
estimated to be completed by December 2009, with final data collection for primary outcome estimated to be February 2010.
Dr. Craig Dees, Ph.D., CEO of Provectus said, "As a topical gel, PH-10 offers many potential advantages over available treatments for psoriasis. In
particular, because it is applied onto the skin, it works directly on the psoriasis, without the likelihood of producing adverse systemic side effects
that characterize many other therapies. With all patients now enrolled, we look forward to the completion of this trial."
He concluded, "The completion of patient accrual for this trial marks the third trial for which we have completed patient accrual within the past five
months. I believe this demonstrates the level of commitment our company has to developing our product pipeline of drugs, PV-10 and PH-10, and
bringing to market drugs that are efficacious and safe for our target oncological and dermatological indications."
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.
About 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. Rose Bengal is a compound that has been in use for nearly 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. (www.pvct.com)
Provectus Pharmaceuticals specializes in developing oncology and dermatology therapies. Its lead oncology agent, PV-10, is designed to selectively target and destroy cancer
cells without harming surrounding healthy tissue, significantly reducing systemic side effects. Its oncology focus is on
melanoma, breast cancer and metastatic liver cancer. The Company has received orphan drug designation from the FDA for
its melanoma indication. Its lead dermatological drug, PH-10, also targets abnormal or diseased cells, with the current
focus on psoriasis and atopic dermatitis. Provectus has recently completed enrollment in two of its Phase 2 trials --
PV-10 as a therapy for metastatic melanoma, and PH-10 as a topical treatment for atopic dermatitis. It is currently
conducting a Phase 2 clinical trial for PH-10 as a topical treatment for 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.
SOURCE: Provectus Pharmaceuticals, Inc.
Contact:
Provectus Pharmaceuticals, Inc.
Peter R. Culpepper, CFO, 866-594-5999 #30
OR
Porter, LeVay & Rose, Inc.
Marlon Nurse, VP - Investor Relations
Bill Gordon, SVP - Media Relations
212-564-4700
