Provectus cancer treatment well tolerated in phase 1 trial of PV-10
The first group of subjects have completed treatment in Provectus Pharmaceuticals’ Phase 1 clinical trial of PV-10, also known as Provecta, and that the treatment was well tolerated at the initial lower dose level. The study is being conducted at two dosage levels with both dosage levels having the potential for showing safety, preliminary efficacy, and the "bystander effect." The authorized dosage will now be increased to the maximum level for treatment of the remaining subjects, Provectus Pharmaceuticals announced here.
PV-10 is the company's lead cancer agent and is being evaluated for safety and preliminary efficacy in a total of 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 centres, both located in New South Wales, Australia, a country where the incidence of melanoma is more than twice that of the United States.
Eric Wachter, executive vice president and head of the company's pharmaceutical development program, noted, "The initial data is very encouraging and appears comparable to the response we've seen in each of our preclinical studies. While this is exciting, it is important to remember that even if this study proves to be successful, further study will be necessary to definitively demonstrate efficacy."