Provectus Pharmaceuticals has announced the commencement of Phase 1 study of PV-10 injection to elucidate bystander effect at the Moffitt Cancer Center.
The study is designed to assess the possible immune biomarkers in both tumor tissue and peripheral blood subsequent to intralesional PV-10 injection of melanoma tumors.
The University of South Florida faculty member, Moffitt experimental therapeutics program member and study principal investigator Amod Sarnaik said, "These results should help elucidate the immunologic basis of the 'bystander effect' noted in previous clinical studies of PV-10 and help optimize PV-10 treatment, particularly in combination with other therapies."
Study, which will enroll up to 15 subjects, is expected to provide information useful in understanding the potential systemic benefit of PV-10 treatment.
The data is believed to suggest reasonable therapeutic combinations with the potential to enhance apparent immune response to PV-10 therapy in cancer patients with considerable tumor burden, according to Provectus.
