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news.The first patients have completed treatment in Provectus Pharmaceuticals phase I clinical trial of its skin cancer compound PV-10, also known as Provecta.
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PV-10 is the company’s lead cancer agent and is being evaluated for safety and preliminary efficacy in 20 subjects with Stage III metastatic melanoma, which is the most aggressive form of skin cancer. The study is being conducted at two of the world’s leading melanoma treatment and research centers, both located in New South Wales, Australia, a country where the incidence of melanoma is very high.
Each patient enrolled in the study is having one to three tumors treated with a single injection of PV-10 and the local response to the treatment is then being observed for a period of 12 to 24 weeks. Potential effects on nearby untreated tumors (called a “bystander effect”) will also be monitored. It is anticipated that the full study will be finished early next year.
Biotechnology entrepreneur and consultant David Darst, a member of the Provectus Corporate Advisory Board, said, “The initiation of PV-10’s first phase I clinical trial is very positive news, especially since the trial has the potential to show statistically significant efficacy in addition to a safety profile.”