Gathering and connecting different informational tidbits from multiple sources, it is quite possible the bulk of Moffitt's Phase 1 feasibility study to explore PV-10's mechanism of action may already be complete (i.e., enrollment, treatment, preliminary analysis).
By detecting immune cell infiltration into melanomas treated by PV-10, Moffitt researchers (led by Dr. Amod Sarnaik MD) want to find out more about how PV-10 works in melanoma tumors, including if there are changes in the body's immune cells after PV-10 is given, both inside the melanoma tumors and circulating in the blood.
These results build upon Moffitt's prior work presented at SSO in March 2012 (Toomey et al.)* and AACR in April 2013 (Pilon-Thomas et al.)**. They could (should) be very relevant to Provectus' pursuit of breakthrough therapy designation from the FDA, as well as to Big Pharma.
* PV-10 induces anti-tumor immunity (murine model work)
** PV-10 induces systemic immune response in multiple tumor types (murine model work)
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