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Melanoma Clinical Trial Update

  • 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.

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