Provectus Pharmaceuticals has announced top-line final data from its Phase 2 trial of PV-10 for metastatic melanoma.
The new data, on response rate and progression-free survival (PFS), supports previous preliminary data on related topics.
Provectus chief technical officer and study director, Eric Wachter, said the preliminary analyses, using final, fully validated study data, confirm trends previously reported using preliminary data and are also consistent with trends observed in the earlier Phase 1 trial.
"We are now completing full statistical analysis of the data and expect to report these final results in September at ESMO 2012, the annual meeting of the European Society for Medical Oncology," Wachter added.
The final data from the 80 subjects in the Phase 2 study include an objective response rate (OR) of 50% in subjects’ target lesions, 70% disease control in these lesions and 33% of subjects having an untreated bystander melanoma lesion achieve an OR in their bystander lesions, while 50% achieved disease control in these lesions.
The data analysed revealed that Stage 3 subjects experienced a substantially higher response rate (58% OR and 81% disease control) versus Stage 4 subjects (22% and 33%, respectively).
The temporal data analysis showed that Stage 3 subjects also experienced significantly greater mean progression-free survival of at least 9.6 months, versus 3.1 months for Stage 4 subjects.
During the 12-month study interval, median PFS for Stage 3 subjects was not reached.
Medical oncology and haematology chief at St Luke’s Hospital and Health Network and principal investigator in the PV-10 Phase 2 trial, Sanjiv Agarwala, said: "These results are quite remarkable, confirming that a robust response can be achieved with PV-10, particularly in Stage 3 patients where it is possible to inject all, or virtually all, of the patient’s melanoma lesions."