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news.Provectus Pharmaceuticals, a development stage company that specializes in oncology and dermatology therapies, has started recruitment for its Phase II clinical trial of the company's lead oncology agent PV-10 at a fifth major center, now covering the northeastern US, in addition to Sydney, Brisbane and Adelaide, Australia, as well as MD Anderson in Houston, Texas, US.
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Sanjiv Agarwala will serve as principal investigator at the new center, located at St Luke’s Hospital & Health Network, in Bethlehem, Pennsylvania. 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 US.
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 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.
According to the company, 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.
Craig Dees, CEO of Provectus, said: “Opening the center at St Luke’s is a logical continuation of our expansion of our Phase II program in melanoma to multiple sites including the US. It is another important step in our effort to get the treatment available to as many patients as possible in the shortest possible time.”