Here's the bottom line. 50 percent of the patients in the earlier cohorts demonstrated at least a 10% increase in p21. At the time, Menon said the trial was progressing with data to date on par with their laboratory data. That's impressive!
Leo thinks activation of p21 in early cohorts is a home run.
"A: We are anticipating the tests to be run in mid-March and the results to follow shortly thereafter. Honestly, we were extremely pleased that the Dana-Farber laboratory is running these tests so early in the trial. It is a "no lose" situation for us as we did not anticipate biomarker testing, nor did we expect to see any activity, at this early stage and low dosing levels. If p21 activity is shown, we think that we have hit a home run, but if activity is not demonstrated, we will not be the least bit disappointed at this juncture in the trial. We will simply then wait for the testing at higher doses as we expected, where we are very optimistic that we will see p21 expression at that time."
Maybe because my background is biochemistry, I understand the significance of that statement better. The combination of the preclinical data and the current progress of the Phase 1 trial leads me to believe that Kevetrin will be a major breakthrough in oncology.
But it does mean that reported changes in p21 are unimpressive for early cohorts.
Infinity, if I understand you, you're saying a 10% increase is not large on an absolute level, and there is no indication that the rate of increase grows in the later cohorts' larger doses, just management saying its going up "as expected", which is mathematically ambiguous, therefore a definitive answer will have to await the results.
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