December 20, 2012
$PVCT: More Data Is Necessary Until It Isn't
PV-10: Big Pharma clearly recognizes a group of drug compounds have local and distant effects on lesions, substantiating the hypothesis injections of these drugs in local tumor lesions result in systemic effects. PV-10 works more easily and effectively. It took Moffitt time, effort and work to begin to wrap their heads around this "phenomena." In the process, they could confirm the first, second and last solution PV-10 may well be (e.g., a pre-surgery treatment).
PH-10: If the premise is that PH-10 has no toxicity, and that the "normal rules" of treatment do not apply, what then? Even though Provectus likely has sufficient directionally positive clinical data for a dermatology transaction, immunologic MOA characterization work, as I previously wrote about, would be helpful with the FDA in designing toxicity studies appropriate for an approved drug. This work should make dermatology companies more desirous of PH-10. The immunologic MOA characterization work came to the forefront when management was working on the remaining toxicity studies for the FDA. When they had difficulty finding any dose limiting toxicity (DLT) or maximum tolerable dose (MTD), they sought to better understand PH-10's unique lack of toxicity.
The answer? Big Pharma just might need more data than otherwise would have been necessary before pulling the trigger(s).
* "The holy grail for cancer would be to trigger the body’s own immune system to fight off the cancer, so that you somehow stimulate the antibodies in a way that that happens." Fareed Zakaria, Fareed Zakaria GPS