Provectus Pharmaceuticals, Inc. (OTC BB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, announced today that initial one year overall survival data from the first 20 subjects in the current Phase 2 trial showed comparable trends to Phase 1 survival data. Survival data for the Phase 1 study of PV-10 for metastatic melanoma continues to show markedly longer overall and disease specific survival for subjects that were responsive to PV-10 relative to those who did not experience a robust response. Survival data was available through early November 2009.
Additionally, several subjects in the responsive group also exhibited one or more indicators of the bystander effect (spontaneous regression of untreated tumors after PV-10 treatment of other tumors), including the first evidence of regression of visceral metastases in two of five subjects in this group who had documented visceral metastases at enrollment.
Professor John F. Thompson, MD, Professor of Melanoma and Surgical Oncology at the University of Sydney, Director of the Melanoma Institute Australia, and Lead Investigator of the Phase 2 study of PV-10 for Metastatic Melanoma, presented these data at the 3rd World Meeting of Interdisciplinary Melanoma/Skin Cancer Centers on November 21, 2009 in Berlin, Germany. His presentation was entitled “PV-10 in the Local Treatment of Melanoma Metastasis.” Professor Thompson noted that “these results are consistent with the expectation of a favorable long-term outcome for responsive patients.”
In addition to the overall survival data for the Phase 1 and Phase 2 trials, Professor Thompson also provided an update on data from the expanded access use of PV-10 in Australia and the United States (“Compassionate Use”). Thompson noted that a total of 15 subjects have commenced treatment with PV-10 under the program, which has been implemented at five of the Phase 2 study centers. This includes 7 subjects that have crossed over from the Phase 2 study to receive further treatment with PV-10, five of whom are now in long-term follow-up. An additional eight subjects with metastatic melanoma have initiated treatment with PV-10 under the program, with five continuing in long-term follow-up.
Craig Dees, PhD, CEO of Provectus said, “We are very excited by these new results presented by Professor Thompson, especially the first reported objective evidence of potential systemic benefit in visceral organs. We look forward to the possibility of augmenting these results with data from the next 20 subjects, which we expect will be available in the first quarter of 2010. Progress with our expanded access program for PV-10, the means through which certain qualified patients can receive PV-10 on a compassionate use basis, is also heartening as we continue development of the agent toward licensure.”
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