Provectus reports Phase 2 data for metastatic melanoma treatment formulation

Provectus said PV-10 is a proprietary, injectable formulation of Rose Bengal used for almost 30 years to assess damage to the eye.

It has also been used as an intravenous diagnostic to detect liver ailments.

It is also selectively toxic to cancer calls through a process called chemoablation in which cells undergo a form of cell death that mimics both necrosis and apoptosis.

Chemoablation of cutaneous melanoma lesions with PV-10 was performed on 80 subjects, and results indicated an Objective Response (OR) in 49% of subjects, with 71% of subjects achieving locoregional disease control (stable disease or better) in their injected lesions.

A mean Progression Free Survival (PFS) of 11.7 months was seen in subjects achieving an OR.

Statistically, the obtained data was equivalent to the interim Phase 2 data on the first 40 subjects, which was presented by principal investigator for the study and St. Luke’s Hospital and Health Network chief of medical oncology and hematology Agarwala at ASCO (American Society of Clinical Oncology) in June 2010.

Agarwala said the consistently positive data and the response rate in patients with cutaneous or nodal disease illustrate the potential of the drug for these prime candidates for PV-10. He also said that the bystander effect, which appears to result from an immunologic response stimulated by PV-10 chemoablation, is especially intriguing.

Provectus CEO Craig Dees said the company was currently incorporating guidance received from the FDA during the End-of-Phase 2 meeting to finalize the protocol design for a pivotal Phase 3 randomized controlled trial suitable for Special Protocol Assessment.