Provectus Announces New Positive Data from Phase II Trial of PV-10 for Metastatic Melanoma

Provectus Pharmaceuticals, Inc., announced additional positive data from its Phase 2 clinical trial of PV-10 for metastatic melanoma at the American Society of Clinical Oncology (ASCO) 2010 Annual Meeting. The data, on changes in visceral and nodal metastases following chemoablation of cutaneous melanoma lesions with PV-10, was presented by Dr. Sanjiv Agarwala at the meeting, on Sunday, June 6, 2010, in the General Poster Session on Melanoma/Skin Cancers (Abstract #8534). Dr. Agarwala is the Chief of Medical Oncology and Hematology at St. Luke’s Hospital and Health Network in Bethlehem, PA, and Principal Investigator for Provectus’s Phase 2 PV-10 trial site at St. Luke’s. According to a company-issue press release, positive improvement observed in these remote, untreated lesions, including metastases to the lungs, liver and brain, illustrate a potential systemic effect in visceral organs to which melanoma has spread. Dr. Agarwala’s updated information included data from the initial 40 patients and the final 40 patients enrolled in the Phase 2 trial. Dr. Agarwala presented summary data on 20 patients, including initial data on four patients from the final 40 patients in the study, who had evidence of macroscopic metastases of the lung, liver, brain or lymph nodes at screening. According to the data presented, of first 40 study participants, 7 of the 16 patients (44%) with visceral or macroscopic nodal metastases at screening exhibited stasis or regression of their lesions, including complete regression of multiple pulmonary metastases measuring up to 1.1 cm in one patient. Detailed data were presented on one Stage IV patients who experienced complete regression of multiple lung metastases and partial regression of multiple brain metastases over the study interval. The supplemental data presented at ASCO was in addition to data announced on May 21, 2010, which included 52-week data on the first 40 patients enrolled in the study: • Objective Response of PV-10 injected lesions was achieved in 60% of subjects, with a Complete Response (CR) in 33% of subjects and locoregional disease control (Stable Disease [SD], or better) in 80% of patients; • An OR was achieved in untreated bystander lesions in 43% of patients having an evaluable bystander lesion at baseline; • Mean Progression Free Survival (PFS) was 8.5 months for all patietns, while the OR cohort had a significantly longer PFS estimated to be at least 11.1 months vs. 3.0 months for SD and Progressive Disease (PD) patients; and • PV-10 was well tolerated, with adverse experiences (AEs) that were generally mild to moderate, locoregional and transient, with no deaths or life-threatening experiences attributable to PV-10. Provectus expects to announce complete final study results at Melanoma 2010 in Sydney, Australia, November 4-7, 2010.