Provectus Pharmaceuticals, Inc. (OTCBB: PVCT, http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company, announced that final efficacy data from its Phase 2 trial of PV-10 in patients with Stage III-IV melanoma will be presented, including response rate and time-to-event (progression free survival “PFS” and overall survival), at the ESMO 2012 (European Society for Medical Oncology) Congress in Vienna, Austria on October 1, 2012. These data serve as the basis for planned Phase 3 testing of PV-10 in Stage III melanoma patients with recurrent, in-transit or satellite metastases. A randomized controlled trial to assess PFS against standard care is expected to commence in late 2012 or early 2013 at centers in the USA, Australia and the EU.
Intralesional rose bengal (PV-10) is being investigated for treatment of solid tumors, where it may elicit selective chemoablation of injected lesions and a tumor-specific, immune-mediated bystander response in untreated bystander lesions (i.e., immuno-chemoablation).
The data are included in Abstract #1137P, “Immuno-chemoablation of metastatic melanoma with intralesional rose bengal,” and will be presented by Dr. Sanjiv Agarwala, M.D., Principal Investigator for the PV-10 Phase 2 trial, and Chief of Medical Oncology and Hematology at St. Luke’s Hospital and Health Network in Bethlehem, PA. The poster is authored by Dr. Agarwala along with co-authors J.F. Thompson, B.M. Smithers, M. Ross, B.J. Coventry, D.R. Minor, C.R. Scoggins and E. Wachter. It will be presented during Poster Presentation III, in Hall XL, from 1:00 p.m. – 2:00 p.m. local time. The abstract can be accessed at the following link:
Dr. Craig Dees, PhD, CEO of Provectus said, “We are looking forward to Dr. Agarwala’s presentation at ESMO, and are particularly encouraged about PV-10′s favorable safety and efficacy profile compared with available options for patients suffering from metastatic melanoma. We are also pleased to have this data presented to a prestigious global audience of medical oncologists, as we continue in our path towards regulatory approval of PV-10.”