Provectus Pharmaceuticals has completed the treatment portion, including all protocol-allowed retreatments of all patients, of phase 2 clinical trial of PV-10 for metastatic melanoma.
PV-10 is a injectable formulation of Rose Bengal. The study involved treatment of 80 subjects with Stage III or Stage IV metastatic melanoma.
The primary objective of the phase 2 study is to investigate the effectiveness of intralesional (IL) PV-10 for locoregional treatment of metastatic melanoma. The study also includes assessment of response in untreated bystander lesions following intralesional injection of PV-10 into treated lesions.
Craig Dees, CEO of Provectus, said: “Completing this portion of the phase 2 trial of PV-10 for metastatic melanoma is an important milestone in our efforts to develop a new treatment alternative for this horrendous disease. With compelling interim data presented at the American Society of Clinical Oncology (ASCO) a few months ago, completing this phase of the study furthers our PV-10 development efforts.
“As we prepare to seek additional guidance from the FDA regarding the actions we need to take to obtain approval for this treatment, we are concurrently taking steps to either seek licensure agreements and/or partnerships that would facilitate final development of this novel oncology drug. We believe PV-10 is a promising therapy that could be of great value to our company and our potential partners.”