Provectus Pharmaceuticals announced today that it has obtained final clearance to begin the first Phase 1 clinical trial of PV-10, the Company’s lead cancer treatment.
The study is designed to evaluate the safety and preliminary efficacy of PV-10 in 20 subjects with Stage III metastatic melanoma (the most aggressive form of skin cancer). PV-10 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 (called a “bystander effect”) will also be monitored.
According to the Melanoma Research Foundation, melanoma is the fastest growing cancer in both the U.S. and worldwide with more than 53,000 new cases (or 1 in 74 people) diagnosed each year in the U.S. 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 U.S. Clearance has been received upon review of the study by each institution’s ethics committee and assignment of a clinical trial number from the Australian Therapeutic Goods Administration under the Clinical Trials Notification scheme. Subject enrollment and treatments are expected to begin immediately.
PV-10 is an agent that is retained in tumor cells while leaving normal tissue unharmed, thereby killing the tumor cells and sparing healthy tissue.
Provectus CEO Craig Dees, Ph.D., noted, “The Phase 1 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 pre-clinical 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. The treatment has been highly effective against spontaneous tumors in a number of animals, including mice, dogs, cats, and horses.”
Eric Wachter, Ph.D., Executive Vice President and head of the Company’s pharmaceutical development program, noted, “We chose to begin clinical testing of PV-10 in Australia, due to the high rate of melanoma incidence and because of the superb study infrastructure and an abundant subject population. Not only is this an excellent starting point for our oncology clinical program, but it also allows us to gain important experience in a potentially important market for PV-10.”