Provectus Pharmaceuticals, Inc. (OTC BB: PVCT) announced that they have commenced recruitment for their Phase 2 clinical trial of the company’s lead oncology agent PV-10 at a fifth major center, now covering the northeastern United States. The new center joins the other company’s centers located in Sydney, Brisbane and Adelaide, Australia, and Houston, Texas.
Sanjiv Agarwala, M.D. has been appointed as the principal investigator at the new center, located at St. Luke’s Hospital & Health Network, in Bethlehem, PA. Over the next several months, the company intends 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.
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. Within the study, PV-10 will be 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.
“This clinical trial represents a promising option for patients with advanced melanoma that have tumors amenable for direct injection,” stated Dr. Agarwala, Section Chief, Hematology/Oncology for St. Luke’s.
“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.,” stated 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 updates on the study are planned for the Clinical Oncology Society of Australia (COSA) meeting to be held on November 19, in Sydney, Australia. Professor John F. Thompson, M.D., will providing a thorough review of Phase 1 results and interim safety data from the first 20 subjects in the Phase 2 study.
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