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We have now just about finished cohort 1 with just the week of observation left to go. Is this a noteworthy achievement or was this first cohort success a given prior to beginning? Will cohort 2 be that stressful regarding patients being able to tolerate the dose or will we only get to the crux of the matter in the latter cohorts, say 4 and above? In what cohort does the scientific team expect the real data to start coming about to define if the MTD is high enough for patients to have tumors shrink without reaching toxicity/tolerance problems and they would say Kevetrin succeeded in Phase 1 of the trials?
I am not worrying at this time about any other factor in regards to deeming cohort 1 a success other than the patients were able to tolerate the dose with no/little ill effects. I have heard that our dose 1 was much higher than normally is given in clinical trials due to the fact that we are dealing with terminal patients and getting to the MTD quicker than normal was a priority. If so, then this would make me feel cohort 1 was more of a success than observed in most other clinical trials.
I think cohort 1 was a success due to no PR being issued that patients reacted badly to the first dose and thus I am assuming the human liver is accepting Kevetrin somewhat along the lines of how the lab animals accepted the drug. Is this thinking flawed or not in the eyes of the scientific team?
Bottom line - Do we really have much to feel good about yet regarding the trials or are we so early in the trials that nothing regarding tolerance for Kevetrin can be established yet?
Input from the scientific team, especially seel, is always appreciate.
TIA
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