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)
Showing posts with label mechanism of action. Show all posts
Showing posts with label mechanism of action. Show all posts
May 11, 2013
December 22, 2012
$PVCT: Fight The Power, Or Play The Game?
Information technology, and some other industries, seems so much easier to invest in than life sciences from the perspective of disruptive technology or approaches being able to fully disrupt. To those to whom this is an obvious statement, you are smarter than me.
My experience and ease with information technology has been to focus on how to use technology, not how or why it works. Don't get me wrong. It was, is and probably will be in my nature to figure out the hows and whys, but a childhood friend of mine years ago framed the situation and solution to me very clearly: (paraphrasing) "Figure out what you're going to do with the box and how much (or whether)/how quickly/how long you'll make doing it, and don't sweat too much how or why the box does what it does."
In the same breath (actually, years later, but I figured it out shortly after the above "epiphany"), he said it's important to have a decent or good understanding of how or why technology works the way it does to keep the inventors of it (e.g., academics, scientists, engineers, etc.) honest -- i.e., be able to call bulls@$% when applicable and appropriate.
How important is understanding "mechanism of action" if PV-10 works: so efficaciously, so broadly, so safely, so easily?
Martin Shkreli wrote in his article on TheStreet.com about Oncothyreon's Stimuvax failure that "A drug's mechanism of action is central to its effect. Do not ignore this! Clinical data can be misleading, innocently biased, meaningless, manipulated and sometimes even downright doctored. However, the question, "How does the drug work?" is always critical." I can understand his point of view, because it you think you understand the MOA (or how or why the technology works the way it does), you're more apt to believe that it does indeed do what you see or read it does.
Working still is working.
This March, we read from Moffitt that, via the titles of Provectus PRs, "mechanism of action data on PV-10 demonstrates therapy induces immunologic response" and "intralesional PV-10 treatment leads to the induction of anti-tumor immunity." Will Moffitt, sometime next year, make more profound statements about PV-10?
Like, PV-10: A robust (strong), durable (long-lasting), portable (vaccine-like) immune-mediated response.
Moffitt est argumentum ad verecundiam. "As a statistical syllogism, the argument has the following basic structure:
My experience and ease with information technology has been to focus on how to use technology, not how or why it works. Don't get me wrong. It was, is and probably will be in my nature to figure out the hows and whys, but a childhood friend of mine years ago framed the situation and solution to me very clearly: (paraphrasing) "Figure out what you're going to do with the box and how much (or whether)/how quickly/how long you'll make doing it, and don't sweat too much how or why the box does what it does."
In the same breath (actually, years later, but I figured it out shortly after the above "epiphany"), he said it's important to have a decent or good understanding of how or why technology works the way it does to keep the inventors of it (e.g., academics, scientists, engineers, etc.) honest -- i.e., be able to call bulls@$% when applicable and appropriate.
How important is understanding "mechanism of action" if PV-10 works: so efficaciously, so broadly, so safely, so easily?
Martin Shkreli wrote in his article on TheStreet.com about Oncothyreon's Stimuvax failure that "A drug's mechanism of action is central to its effect. Do not ignore this! Clinical data can be misleading, innocently biased, meaningless, manipulated and sometimes even downright doctored. However, the question, "How does the drug work?" is always critical." I can understand his point of view, because it you think you understand the MOA (or how or why the technology works the way it does), you're more apt to believe that it does indeed do what you see or read it does.
Working still is working.
This March, we read from Moffitt that, via the titles of Provectus PRs, "mechanism of action data on PV-10 demonstrates therapy induces immunologic response" and "intralesional PV-10 treatment leads to the induction of anti-tumor immunity." Will Moffitt, sometime next year, make more profound statements about PV-10?
Like, PV-10: A robust (strong), durable (long-lasting), portable (vaccine-like) immune-mediated response.
Moffitt est argumentum ad verecundiam. "As a statistical syllogism, the argument has the following basic structure:
- Most of what authority A has to say on subject matter S is correct.
- A says P about subject matter S.
- Therefore, P is correct."
"Come, Watson, come! The game is afoot. Not a word! Into your clothes and come!"
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