PV-10, which is designed to be retained in tumor cells while leaving normal tissue unharmed, will be injected into one to three tumors in each subject. The local response to this single injection will be observed for a period of 12-24 weeks thereafter. Potential effects on nearby untreated tumors will also be monitored.
Provectus CEO, Dr Craig Dees, commented, “The phase I study will allow us not only to assess the safety of injecting PV-10 into tumors but also ascertain potential effectiveness since we are testing at efficacy levels. Extensive preclinical studies, using laboratory models of melanoma, breast cancer, and liver cancer, have shown that PV-10 can destroy injected tumor tissue while leaving all other tissue alone.”
According to the Melanoma Research Foundation, melanoma is the fastest growing cancer in both the US and worldwide with more than 53,000 new cases (or 1 in 74 people) diagnosed each year in the US across all age groups; of these, 7,800 or 15 percent are fatal. In addition, according to the foundation, no significant advances in medical therapies (or survival) for patients with advanced melanoma have occurred in the past 30 years.
The study will be conducted at two of the leading melanoma treatment and research centers in the world, located in New South Wales, Australia, a country where the incidence of melanoma is more than twice that of the US.