Health & Fitness
Health and Fitness
Health and Fitness
Mon, December 29, 2008
Wed, December 24, 2008
Tue, December 23, 2008 Provectus Pharmaceuticals Adds Seventh Center to Phase 2 Clinical Trial of PV-10
KNOXVILLE, Tenn.--([ BUSINESS WIRE ])--Provectus Pharmaceuticals, Inc. (OTC BB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, has begun recruitment for its Phase 2 clinical trial of the Company's lead oncology agent PV-10 at a seventh major center located at the University of Louisville, in Louisville, KY. Charles Scoggins, M.D. will serve as principal investigator at the new center.
This seventh site is in addition to Sydney, Brisbane and Adelaide in Australia, as well as M.D. Anderson in Houston, Texas, St. Luke's Hospital & Health Network in Bethlehem, PA, and the California Pacific Medical Center in San Francisco, CA. Based upon enrollment at its other sites, Provectus will evaluate the need to open additional sites for the Phase 2 clinical testing of PV-10 in the United States and Australia to reach its target of 80 subjects.
Phase 2 clinical testing of PV-10 is designed to assess the agent as a treatment for Stage III and IV metastatic melanoma, the most aggressive and deadly form of skin cancer. The multi-center study will evaluate efficacy of PV-10 in a total of 80 subjects. In the study, PV-10 is being injected into up to 20 tumors in each subject. Additional treatment with PV-10 may be made 8 to 16 weeks after this initial injection, if deemed necessary by the investigator. Response will be observed for one (1) year, allowing data to be gathered for assessment of objective response rate, progression free survival, quality of life and safety. An interim assessment of safety and efficacy will be conducted after treatment of the first 20 and first 40 subjects. Details of the study are available at the [ www.ClinicalTrials.gov ] clinical trials registry.
"Opening the center at the University of Louisville fits very well with our planned expansion of our Phase 2 program in melanoma to regional centers of excellence throughout the U.S.," said Craig Dees, Ph.D., CEO of Provectus. "The availability of a superb team combined with Louisville's central location advances our efforts to get the treatment available to as many patients as possible in the shortest amount of time."
Provectus recently announced that enrollment has reached the halfway point in the study. Further update on study status is planned for the Sixth International Symposium on Melanoma and Other Cutaneous Malignancies, March 13-14, 2008 in New York City, where efficacy data on the first 20 subjects, and safety data on the first 40 subjects treated will be presented.
Separately, Provectus announces it has updated its investor presentation on its website. The presentation now includes comparisons of Provectus to other companies in its peer group as well as the dates that it expects to announce preliminary results of the PV-10 phase 2 clinical trial. The updated presentation can be found at the following link on the company's website: [ http://www.pvct.com/presskit.html ].
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.
