Provectus Pharmaceuticals Adds Fifth Center to Phase 2 Clinical Trial of PV-10
News Nov 03, 2008
Provectus Pharmaceuticals, Inc. has begun recruitment for its Phase 2 clinical trial of the Company's lead oncology agent PV-10 at a fifth major center, now covering the northeastern United States, in addition to Sydney, Brisbane and Adelaide, Australia, as well as M.D. Anderson in Houston, Texas, USA.
Sanjiv Agarwala, M.D. will serve as principal investigator at the new center, located at St. Luke’s Hospital & Health Network, in Bethlehem, PA. Over the next several months, the Company expects to continue expansion of the study to include sites in other major population centers in Australia as well as several sites in the United States.
“This clinical trial represents a promising option for patients with advanced melanoma that have tumors amenable for direct injection,” says Dr. Agarwala, Section Chief, Hematology/Oncology for St. Luke’s.
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.ClincalTrials.gov clinical trials registry.
"Opening the center at St. Luke’s is a logical continuation of our expansion of our Phase 2 program in melanoma to multiple sites including the U.S.," said Craig Dees, Ph.D., CEO of Provectus. "It is another important step in our effort to get the treatment available to as many patients as possible in the shortest possible time."
Provectus recently announced that enrollment is nearing the halfway point in the study. Further update on study status is planned for the Clinical Oncology Society of Australia (COSA) meeting, November 19, in Sydney, Australia, where Professor John F Thompson, MD, will review Phase 1 results and interim safety data from the first 20 subjects in the Phase 2 study.