PV-10. Has anyone heard of this stuff? What is it?
http://www.dailyfinance.com/2012/10/02/provectus-pharmaceuticals-presents-final-phase-2-m/
PV-10. Has anyone heard of this stuff? What is it?
http://www.dailyfinance.com/2012/10/02/provectus-pharmaceuticals-presents-final-phase-2-m/
KNOXVILLE, Tenn.–(BUSINESS WIRE)– Provectus Pharmaceuticals, Inc. (OTC BB: PVCT, http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company, announced that final top-line data from its Phase 2 clinical trial of PV-10 for metastatic melanoma were presented at the ESMO (European Society for Medical Oncology) 2012 Congress in Vienna, Austria on October 1, 2012. The data were presented in Poster Presentation III, Abstract #1137P, "Immuno-chemoablation of metastatic melanoma with intralesional rose bengal." The poster was presented by Dr. Sanjiv Agarwala, M.D., Principal Investigator for the Phase 2 trial of PV-10, and Chief of Medical Oncology and Hematology at St. Luke's Hospital and Health Network in Bethlehem, PA. The poster was 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.
- An Objective Response Rate (OR) of 51% in subjects' target lesions (25% Complete Response and 26% Partial Response);
- 69% disease control in these lesions (combined Complete, Partial and Stable Response subjects);
- 33% of subjects having an untreated bystander melanoma lesion achieved an OR in their bystander lesions while 50% achieved disease control in these lesions;
- Response of bystander lesions was highly correlated with outcome in treated target lesions, with a bystander lesion OR of 61% in subjects achieving complete or partial response in their target lesions versus 18% bystander lesion OR in subjects that did not achieve this level or response in their target lesions;
- Stage III subjects experienced a substantially higher target lesion response rate (60% OR and 79% disease control) versus Stage IV subjects (22% and 33%, respectively);
- Similar trends were noted in response metrics for bystander lesions between these two subpopulations;
- Analysis of temporal data showed that Stage III subjects also experienced significantly greater mean Progression Free Survival (PFS) of at least 9.7 months, versus 3.1 months for Stage IV subjects (median PFS for Stage III subjects was not reached during the 12-month study interval);
- Overall survival (OS) data were also presented by disease stage, with Stage III subjects achieving a mean overall survival of at least 12.6 months (median not reached during the study interval) versus 7.3 months for Stage IV subjects.
- Case studies on several subjects illustrated potential stasis or regression of untreated visceral lesions following PV-10 treatment of their cutaneous lesions, while data on long-term treatment of one study participant demonstrated successful management of the disease over a period exceeding 3 years.
Dr. Eric Wachter, PhD, Chief Technical Officer of Provectus and Study Director for the clinical trial, noted that, "These final analyses confirm previously reported trends from preliminary data. The high response rates for target and bystander lesions in Stage III subjects are particularly striking and illustrate the potential for PV-10 to benefit these challenging cases."
Dr. Agarwala, commenting on the reported data, stated, "These results further confirm the robust response that can be achieved with PV-10. This is particularly clear in Stage III patients where it is possible to inject all or virtually all of the patient's melanoma lesions. Despite the strict limits on dosing schedule in the Phase 2 protocol, many of the patients achieved excellent disease control or even complete remission. I find it quite remarkable that this included a number of subjects who experienced favorable response in their untreated skin or visceral lesions."
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I never heard of this stuff and it certainly does look promising, especially for those who have Stage III mel.
