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Pernix Therapeutics Holdings, Inc. Message Board

yyyprionyyy 1 post  |  Last Activity: Sep 30, 2014 2:26 AM Member since: Jan 13, 2004
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  • 6:17 am Provectus Pharma data presented at ESMO 2014 Congress show ablative, bystander effects of PV-10; data enables design of Phase 3 RCT for melanoma (PVCT) : Co announced that data on its investigational agent PV-10 for intralesional treatment of locally advanced cutaneous melanoma was featured in a poster presentation on Sep 28, 2014 during the European Society For Medical Oncology 2014 Congress in Madrid, Spain.

    The presentation showed that PV-10 elicits a high rate of response in injected tumors through its ablative effect, and additionally, that the durability of response as well as the bystander response in uninjected tumors implicate an additional immunologic mechanism secondary to ablation.
    Tumors were no longer detectable (complete response or CR) in 26% of the study population. This response was particularly evident in patients who had all existing lesions injected with PV-10 (i.e., All Lesions Treated subgroup, 50% CR; Confidence Interval: 31-69%). These 28 patients had as many as 20 lesions confined to the skin, and experienced a mean PFS of 9.8 months. For an additional 26 patients who had all their disease treated with the exception of 1-2 designated, untreated bystander lesions, mean PFS was 8.9 months. +
    These data from this subgroup analysis support the potential of PV-10 as a single agent and provide a rationale for a PV-10 phase 3 randomized controlled trial in locally advanced melanoma patients.

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