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noretreat

02/12/15 9:44 AM

#91343 RE: frrol #91342

There is really no way to know whether or not the P21 data so far are good. The reason is that virtually no one has ever been able to move that needle at all.
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Drano

02/12/15 9:50 AM

#91344 RE: frrol #91342

I disagree. 10% response at low dose is actually good, since there have been indications (from the stuff they've said) that they think response may be dose-dependent.

If you saw the Wright Brothers' first flight would you say that the fact that it could be measured in seconds means that longer flights are impractical?
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scottsmith

02/12/15 9:56 AM

#91346 RE: frrol #91342

"Among patients enrolled in the 8th cohort of the ongoing Kevetrin trial, results showed SIGNIFICANT ENHANCEMENT OF P21 EXPRESSION IN 50% OF THESE PATIENTS!!!. These findings represents a positive signal for the potential efficacy of Kevetrin in the treatment of cancer."
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Whoops

02/12/15 2:03 PM

#91371 RE: frrol #91342

frrol, I absolutely disagree. They are not injecting Kevetrin directly in to cancer tumors its entering the blood and looking for them. Also to note here is that Kevetrin clears out fast too probably why the company is looking at dosing twice a week in future trials. There is ~100 billion cells in the human body. The 10% or better increase in p21 at low doses (think dilution) the highest of which may have only been 50mg/m2 for perspective we are now dosing at 450mg/m2 a 9x increase from the highest dose included in that 50% mark.

Part of the problem for me is that I don't know what normal levels of p21 are or perhaps more importantly how much it can vary in a individual without Kevetrin. But I am pretty certain that 10% increase threshold came from Dana Farber and know one would know better. That 10% mark removes any "natural" variability that might occur in p21. A little deceptive perhaps only in hindsight is that Kevetrin started dosing at very, very low levels perhaps more so for a chemo type drug but of course they followed protocol.

The smartest chap I know working in one of our research satellite labs here at the UW told me, after giving him all the details he has done p21 testing before, that we would probably see increases in p21 within the first 3 cohorts. And he was right, I posted this on this board some years ago. When asked how much of an increase one might expect to see he said maybe 2-3%.

To stick the bullet in the chamber and remove all doubt we need to see increasing p21 with increasing doses of Kevetrin.


"That p21 data is pretty important. Hopefully it shows higher response at higher K doses. The preliminary low-dose results were OK, not great. Anyone disagree?"