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.