Thoughts on Moffitt

I have been trying to succintly articulate the narrative of the impact or potential impact of the Moffitt results presented last month, the cancer center & research institute's on-going work that has not yet been presented and contemplated future work.

More than just the impact of the results or the outcome of the work, which appear to be sublime, what are the takeaways?

Moffitt:

• Independently confirmed (demonstrated the reproducibility of) the local and systemic effects (benefits) of PV-10, although the primary focus of the work was the drug's systemic (bystander) effect;
• Identified quintessential immune-mediated response: Splenocytes from PV-10 treated mice produced interferon-γ in response to B16-F10 melanoma cells (p<0.05); and,
• As important as reproducing Craig et al.'s work, demonstrated the veracity of the founders' initial work. Moffitt's work, to me, [continue to] show that Craig, Tim and Eric are accurate and honest. What they say is what we get.

This last is crucial to appreciating the veracity of other ideas, proof-of-concept work, pre-clinical work (e.g., murine models, animal tumors) and non-trial clinical work (e.g., compassionate use program) and, thus, their highly likely potential and value upon eventual implementation.

We have yet to find know if Moffitt has [successfully]:

• Demonstrated multi-indication viability. That is, has Moffitt successfully repeated their approach and shown comparable systemic effects using other cancers besides metastatic melanoma?
• Elucidated the breadth and depth, so to speak, of the immune-mediated response and systemic effect?

Interestingly, I think Moffitt's work also provides:

• A very nice story for some medical academicians and clinicians to better understand, more comfortably grasp onto and/or more heartily embrace the first-line, widespread and pervasive use of PV-10;
• A very nice marketing prop for some big pharma executives to communicate the value proposition and value of the first-line, widespread and pervasive use of PV-10; and,
• Provides internal justification for the FDA to grant accelerated approval for the use of PV-10 to treat metastatic melanoma.