Provectus Pharmaceuticals Adds Seventh Center to Phase 2 Clinical Trial of PV-10
News Dec 26, 2008
Provectus Pharmaceuticals, Inc. 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 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.”