Provectus Pharmaceuticals, Inc. (OTCQB: PVCT,
), a development-stage oncology and dermatology biopharmaceutical company, announces that analysis of data from its completed Phase 2 study of intralesional PV-10 in metastatic melanoma will be presented at the upcoming European Cancer Congress (ECCO 17- ESMO-38 - ESTRO 32), taking place September 27 through October 1, 2013 in Amsterdam, The Netherlands.
PV-10, a 10% solution of Rose Bengal that is currently being examined as a novel cancer therapeutic, is designed to selectively target and destroy cancer cells without harming surrounding healthy tissue, minimizing potential for systemic side effects. The international, multicenter, Phase 2 study of 80 subjects with AJCC Stage IIIB-IV melanoma examined the effect of up to 4 treatment cycles of intralesional (IL) PV-10 in patients with refractory, locally advanced disease. Interlesional PV-10 tumor ablation provided, with minimal intervention, rapid locoregional disease control. The high rate of bystander lesion response and reversible cutaneous locoregional blistering (prognostic for patient response), are consistent with the novel tumor-specific immune mediated mechanism of action of PV-10.
As previously announced, this data from the Phase 2 study was submitted and accepted for presentation at ECCO. Abstract No. 3.755, entitled, "Locoregional Disease Control in Metastatic Melanoma: Exploratory Analysis From Phase 2 Testing of Intralesional Rose Bengal," is authored by S.S. Agarwala, J.F. Thompson, B.M. Smithers, M.I. Ross, B.J. Coventry, D.R. Minor, C.R. Scoggins, J. M. Singer and E.A. Wachter, and can be accessed at the following link:
In the phase 2 study, up to 10 cutaneous or subcutaneous target lesions and up to 10 additional non-target lesions received intralesional PV-10 at day 0 and could be reinjected as necessary at weeks 8, 12 and 16 if tumor tissue remained. Up to 2 additional cutaneous or subcutaneous lesions were left untreated to assess bystander response. The primary endpoint in the single arm trial was best overall objective response rate (BORR) judged by RECIST in each subject’s target lesions.