Provectus Pharmaceuticals Adds Fourth Center to Phase 2 Clinical Trial of PV-10
News Oct 20, 2008
Study sites now cover Adelaide, Australia in addition to Sydney and Brisbane, Australia, as well as M.D. Anderson in Houston, Texas, USA. 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.
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.ClincalTrials.gov clinical trials registry.
"Opening the center at Adelaide is the 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."
In Phase 1 testing, in more than 100 metastatic melanoma tumors in 20 subjects, PV-10, which has received orphan drug designation in the U.S., was well tolerated with generally mild side effects. Dr. Dees noted, "The 40% objective response rate and 75% rate of disease control observed in the initial study bode well for success of PV-10 for treatment of this most challenging of cancers." In oncology, objective response is achieved when a subject’s lesions shrink or disappear, while disease control includes those subjects whose lesions remain constant in size.
The lead investigator for Provectus’ Phase 2 melanoma study, Professor John F Thompson, MD, noted recently at Perspectives in Melanoma XII that after 32 subjects had been treated, the interim Phase 2 data was consistent with the findings from the Phase 1 study. Further update on study status is planned for the Clinical Oncology Society of Australia (COSA) meeting, November 18-20, in Sydney, Australia.