Provectus Announces First Peer-Reviewed Publication on PV-10 in "Melanoma Research"
KNOXVILLE, Tenn.--(BUSINESS WIRE)--Oct 14, 2008 - Provectus Pharmaceuticals, Inc. (OTC BB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, announced that "Melanoma Research" has published a paper entitled, "Chemoablation of metastatic melanoma using intralesional Rose Bengal," on its website. The paper is authored by Professor John F. Thompson, M.D. and his colleagues, Professor Peter Hersey, M.D. and Eric Wachter, Ph.D. The paper details results of Provectus' Phase 1 clinical trial of PV-10, and is scheduled for print publication in the December issue of the journal.
The paper presents clinical data for the first 11 subjects in the Phase 1 trial. In this initial cohort, up to three target lesions were injected in each subject, with up to 3 additional nontarget lesions remaining untreated for observation of a bystander effect.
According to the paper, twenty-six target lesions were injected with PV-10, and an additional 28 lesions were observed without treatment to assess the bystander effect. The authors note, "The treatment was well tolerated and an objective response was observed in 12 target lesions, with an additional seven lesions remaining static over at least 12 weeks of observation. In this dose-evaluation study, response rate was dose dependent, increasing to 69% after higher dose injections. Nontarget lesions exhibited a 27% objective response rate that increased to 44% in patients exhibiting a positive response of target lesions. These findings indicate that intralesional Rose Bengal is nontoxic and could benefit patients with metastatic melanoma."
Professor Thompson concluded, "The preliminary efficacy and side-effect results from single IL treatment sessions with PV-10 compare favorably with those of other IL regimens for melanoma."
Craig Dees, CEO of Provectus, noted, "Full results from the study were reported on October 2, 2008 by Professor Thompson at the Perspectives in Melanoma XII conference in The Hague, The Netherlands, and are consistent with the initial results detailed in this journal article. As noted by Thompson during his presentation, initial safety results from our expanded Phase 2 clinical trial of PV-10 for metastatic melanoma are also consistent with this Phase 1 safety profile, and with the opportunity to treat lesions more than once in the Phase 2 study, we expect to improve upon the exceptional response noted in Phase 1."
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.
Provectus Pharmaceuticals, Inc.
Peter R. Culpepper, 866-594-5999 #30
Porter, LeVay & Rose, Inc.
Marlon Nurse, VP â?? Investor Relations
Bill Gordon, SVP â?? Media Relations
Posted: October 2008