The Phase II 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 eight 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.
The MD Anderson Cancer Center joins those already announced in Sydney and Brisbane, Australia. Over the next several months, the company expects to continue expansion of the study to include sites in most major population centers in Australia as well as several additional sites in the US.