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news.Provectus Pharmaceuticals, a development-stage oncology and dermatology biopharmaceutical company, has begun recruitment for its Phase II clinical trial of the company's lead oncology agent PV-10 at a sixth major center located at the California Pacific Medical Center, in San Francisco, California. David Minor will serve as principal investigator at the new center covering the western US.
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This sixth site is in addition to Sydney, Brisbane and Adelaide in Australia, as well as MD Anderson in Houston, Texas, and 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 at least one more site in the US.
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.
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. Provectus has recently announced that enrollment is nearing the halfway point in the study.
Craig Dees, CEO of Provectus, said: “Opening the center in San Francisco is a logical continuation of the expansion of our Phase II program in melanoma to multiple sites including the US. It is another important step in our effort to make the treatment available to as many patients as possible in the shortest possible time.”