June 12, 2013

$PVCT White Paper

Provectus' recent white paper effectively is a PR and primarily if not exclusively about getting the FDA's breakthrough therapy designation.

The central message of the paper is part of the uniqueness of PV-10's MOA is the way it works to harness the immune system (the other part of the uniqueness is the very effective chemoablation MOA when delivered intralesionally).

Much like in a fancy restaurant, where you might receive an amuse bouche prior to ordering or receiving food, the paper is an amuse bouche. The appetizer is Moffitt's eventual PR about their upcoming peer-reviewed publication paper describing their murine model work to elucidate PV-10's stimulation of the immune system. The paper itself, thus, is the entree.

The paper describes that PV-10 works very effectively by stimulating the immune system. When stimulation is less effective or ineffective, it is primarily due to excessive tumor burden, an assist is needed to reduce such burden until PV-10 can stimulate the immune system. It is possible, however, that enough PV-10 to further chemoablate could be enough without the need for an assist even in the heaviest tumor burden situations, but more trials likely would have to be run to maximize PV-10's utilization on its own through the entire race.

Notably, more than few people believe PV-10 could provide synergistic results when combined with anti-CTLA4 and anti-PD-1 agents, whereas merely additive results are achieved combined with kinase inhibitors.

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