Melanoma Clinical Trial Update

• In March 2012, abstract #P265 entitled "Intralesional Injection of Melanoma with Rose Bengal Induces Regression of Untreated Synchronous Melanoma in a Murine Model," authored by P. Toomey, K. Kodumudi, L. Martin, A. Mackay, A. Sarnaik and S. Pilon-Thomas of the Moffitt Cancer Center was included in the Society of Surgical Oncology's 65th Annual Symposium Abstract Book and was published in Annals of Surgical Oncology, 2012; 19(1): S125. A poster presentation and detailed experimental data were presented during the Annual Meeting's melanoma poster session. In the study, an immune-mediated anti-tumor response to PV-10 treatment was observed, including induction of tumor-specific interferon-gamma production by splenocytes derived after PV-10 treatment compared to control.
• In October 2011, Craig Dees, Ph.D. presented at the "2nd Annual Cancer Immunotherapy: a Long-Awaited Reality" conference, outlining preliminary results of method of action studies being conducted on animal models and evidence of an "immunotherapy-like" response witnessed in untreated tumors during Phase 1 and Phase 2 clinical trials of PV-10 for metastatic melanoma and liver cancer. Slides from Dr. Dees' presentation are available as a PDF document.
• In June 2011, data was presented by two of Provectus's Principal Investigators for the Phase 2 melanoma study. Professor Merrick Ross, M.D., of the MD Anderson Cancer Center in Houston, Texas, gave a presentation entitled "Intralesional Therapy for Systemic Disease: Implications for Success and Failure," at the HemOnc Today Conference in New York City, providing a comprehensive review of modern intralesional therapies, including PV-10. A video containing slides and audio commentary of Dr. Ross' presentation is available on the HemOnc Today website.
  
  Dr. Sanjiv Agarwala, M.D., Chief of Medical Oncology and Hematology at St. Luke's Hospital and Health Network in Bethlehem, PA, gave a presentation entitled "Chemoablation of Metastatic Melanoma with PV-10" at the 7th EADO (European Association of Dermato-Oncology) Conference in Nantes, France. In his presentation, Dr. Agarwala reviewed Phase 2 data on PV-10 and outlined primary design parameters for a Phase 3 randomized controlled trial of PV-10, noting that the design is based on guidance obtained in meetings with the U.S. Food and Drug Administration (FDA) and the Australian Therapeutic Goods Administration (TGA).
• Fully monitored study data for the entire study population of 80 subjects in the Phase 2 clinical trial of PV-10 for metastatic melanoma was presented by Dr. Sanjiv Agarwala at the 4th Interdisciplinary Melanoma & Skin Cancer Centres Meeting held at the Melanoma 2010 Congress in Sydney, Australia on November 4, 2010. A PDF document containing slides from the presentation, titled "Chemoablation of Metastatic Melanoma with PV-10", may be downloaded at PV-10_Presentation_Sydney-Nov-2010.pdf.
• Additional positive data from the Phase 2 clinical trial of PV-10 for meastatic melanoma was presented at the ASCO 2010 Annual Meeting, Abstract #8534, entitled "Chemoablation of Metastatic Melanoma with Rose Bengal (PV-10)". The presentation poster and a video interview of Dr. Sanjiv Agarwala, Principal Investigator of the phase 2 clinical study conducted at St. Luke's Hospital & Health Network in Bethlehem, PA, is available on the ASCO 2010 Presentation page.
• An article entitled "A novel treatment for metastatic melanoma with intralesional rose bengal and radiotherapy: a case series", was published in the February 2010 issue of Melanoma Research. In the article, physicians involved with the phase 2 clinical trial of PV-10 for metastatic melanoma observe an impressive response in patients receiving radiotherapy after previously being treated with PV-10.
• Interim data on the first 40 subjects treated in the phase 2 study of PV-10 for the treatment of metastatic melanoma were presented at the American Society of Clinical Oncology (ASCO) 2009 Annual Meeting, Abstract #9060, entitled "Chemoablation of melanoma with intralesional rose bengal (PV-10)". A video interview of Dr. Sanjiv Agarwala, Principal Investigator of the phase 2 clinical study being conducted at St. Luke's Hospital & Health Network in Bethlehem, PA, as well as the poster from the ASCO 2009 presentation, is available on the ASCO 2009 Presentation page.
• A paper entitled "Chemoablation of metastatic melanoma using intralesional Rose Bengal", based on the results of the Phase 1 study of intralesional PV-10 chemoablation in subjects with metastatic melanoma, was published in the December 2008 issue of Melanoma Research.
• Professor John F. Thompson, MD presented interim results of the phase 2 clinical trial of PV-10 for melanoma at the 6th International Symposium on Melanoma and Other Cutaneous Malignancies in March 2009.
• Professor John F. Thompson, MD, Director of the Sydney Melanoma Unit, discussed ongoing clinical studies of melanoma treatments at the Sydney Cancer Conference 2008. Professor Thompson is the lead investigator for the phase 2 clinical study of PV-10 for melanoma being conducted at the Sydney Melanoma Unit. A video and transcript of Professor Thompson's presentation at the SCC 2008 is available here.
• A Phase 2 study of intralesional PV-10 in the treatment of metastatic melanoma, (study ID PV-10-MM-02), is currently in progress. The primary objective of this study is to investigate the effectiveness of intralesional (IL) PV-10 for locoregional treatment of metastatic melanoma. More details of the study are available at the U.S. National Institutes of Health ClinicalTrials.gov website.
• A Phase 1 safety and tolerability study of intralesional PV-10 chemoablation in subjects with metastatic melanoma, (study ID PV-10-MM-01), has been completed. The objective of this study was to investigate the safety of intralesional (IL) PV-10 for the treatment of metastatic melanoma. This study also included a preliminary assessment of response of treated and untreated lesions by clinical evaluation at follow-up of 12 to 24 weeks following IL PV-10 treatment. Further details of this study are available at the U.S. National Institutes of Health ClinicalTrials.gov website.
• A short animation is available that depicts PV-10 entering and destroying cancerous cells, while not entering or harming healthy cells.

Continue for further melanoma clinical trial information.