July 27, 2012

Blog Reader Question

"Did it seem as if the current Moffitt studies would be enough to generate real interest among the big pharma companies? That is, if Pfizer doesn't just snatch them up first."

The first round of Moffit's murine studies confirmed that PV-10 chemoablation of melanoma lesions leads to a systemic response and the induction of systemic anti-tumor immunity.

The second round of murine studies could expand this confirmation to several other cancers and further characterize PV-10's systemic benefit. Human trials, slated to begin this summer, would follow thereafter with additional characterization.

Big Pharma interest in PV-10 is of course very real: from the drug's potential role as a local treatment -- to fill the unmet need of and clear demand for effectively treating visible and accessible tumors -- to its systemic benefit -- again, to fill the unmet need where Yervoy and Zelboraf fall short.

The key to aiding Big Pharma's technical assessment of PV-10, aside from clearing up its regulatory path (i.e., SPA), is to elucidate its systemic characterization (i.e., MOA, MOIR). These technical assessment folks want to understand how and why PV-10 works, feeling uncomfortable with black boxes around that which they cannot wrap their heads, ultimately wanting to answer "is it real?"

We can only believe more Moffitt data will answer their questions and spectacularly rock their world in the process.

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