Provectus Lead Investigator Professor John F. Thompson Gives Update on PV-10 Melanoma Study at Clinical Oncological Society of Australia 2008 Annual Scientific Meeting
Provectus Pharmaceuticals, Inc. (OTCBB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, announced that the lead investigator for its phase 2 melanoma study, Professor John F. Thompson, MD, presented an update on clinical testing of PV-10 for metastatic melanoma Wednesday, November 19th, at the Clinical Oncological Society of Australia (COSA) 2008 Annual Scientific Meeting (ASM) in Sydney, Australia. Professor Thompson noted that so far 39 of the planned 80 subjects have received at least one course of PV-10 treatment. In addition, long-term survival data for subjects participating in the phase 1 trial were presented.
Provectus began phase 2 testing of PV-10 in late 2007, aiming to assess PV-10 chemoablation in 80 subjects with Stage III or IV metastatic melanoma. The study is being conducted at centers in Sydney, Brisbane and Adelaide, Australia, and at the M.D. Anderson Cancer Center in Houston, TX, St. Luke's Hospital & Health Network, in Bethlehem, PA, and the California Pacific Medical Center, in San Francisco, CA. Provectus expects to add additional sites in the U.S. and Australia in the near future. The Company has received orphan drug designation from the FDA for its metastatic melanoma indication.
Professor Thompson noted that the PV-10 treatments have been generally well tolerated, with the most common side effect being transient pain during or shortly after injection, reported by about half of subjects. Interim safety data for the first 20 subjects was reported in early October at Perspectives in Melanoma XII. Analysis of interim efficacy data for these subjects is scheduled to commence in late December, when the required 24 week observation period has been completed for all subjects in the cohort. Thompson noted that data from this assessment, as well as interim data from the first 40 subjects, is expected to be presented in March 2009 at the Sixth International Symposium on Melanoma, in New York City.
Thompson also presented updated long-term survival data for subjects participating in phase 1 testing of PV-10, noting that there continues to be a statistically significant difference in survival between those subjects achieving an objective response of their injected melanoma lesions, with a median survival of 30.7 months, versus 12.3 months for subjects failing to respond to PV-10 (P = 0.043). "Since only one of the eight subjects in the positive response group has died from melanoma," Thompson noted, "these data suggest that response of treated lesions may be a good predictor of long-term outcome."
Craig Dees, PhD, CEO of Provectus, commented, "The addition of new centers to the phase 2 study over the past several months has greatly accelerated the rate of subject accrual. We look forward to passing the mid-point of the study very soon, which will allow us to begin the process of conducting our second set of interim analyses, on safety and efficacy for the first 40 subjects. With the anticipated addition of several additional centers in the next several months, we look forward to completing the enrollment portion of the study in the first half of 2009."
According to the American Cancer Society, more than 62,000 people are expected to be diagnosed in the US in 2008 with melanoma, the most serious form of skin cancer, leading to over 8,000 deaths this year.
About Provectus Pharmaceuticals, Inc. (www.pvct.com)
Provectus Pharmaceuticals is a development stage company that specializes in oncology and dermatology therapies that are safer, more effective, less invasive and more economical than conventional therapies. Provectus is currently conducting Phase 2 clinical trials of their proprietary drugs PV-10 as a therapy for metastatic melanoma and PH-10 as a topical treatment for psoriasis and atopic dermatitis. Information about these and the Company's other clinical trials can be found at the NIH registry, www.clinicaltrials.gov. The Company has received orphan drug designation from the FDA for its melanoma indication. Complementing their suite of proprietary drugs, Provectus has developed a number of intellectual properties and technologies in the areas of imaging, medical devices and biotechnology. 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.
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