Provectus Pharmaceuticals has reported that all subjects have been treated in its initial Phase I clinical trial of PV-10 (Provecta) for ablation of recurrent breast cancer.
Treatment with PV-10 was well tolerated by all five subjects, with no evidence of systemic or serious local side effects. Several subjects exhibited evidence of efficacy, including tumor ablation or shrinkage. These results achieve the primary study endpoints of safety and preliminary efficacy assessment.
Based on the promising results of the initial trial, the company is expanding the study to include two additional dose groups (five subjects per group) that will receive progressively higher doses of PV-10. The expanded study is designed to identify the appropriate dose of PV-10 for Phase II/III studies and is expected to begin immediately upon receipt of regulatory approval.