I understand Phase I is to determine MTD and to do that there will be 6 cohorts receiving increasing dosage amounts every month with a dose every week for the first 3 weeks and the last week being an evaluation week. This comes out to 6 months putting us at the end of April when the last cohort finishes. Then we go into 6 months of analyzing the data attained during the study.
What happens if MTD is attained in March? Does that end the cohorts and we go right to the 6 months of evaluation to end Phase I so the finish will be end of Sept? If no tumor shrinkage is noted at MTD are the trials ended and Kevetrin in it's current form deemed a failure? Do we have to get thru all the cohorts for Phase I to be deemed a success? I would think not as the dosage level at the end of cohort 6 had to be just a best guess prior to starting the trials.
So what news are we really wanting to see from this early testing? Obviously we want to see p21 biomarkers, we want to get to a very healthy dose before reaching MTD, most likely we need to see tumor shrinkage but is Kevetrin still in the running if we don't, and what else? If tumor shrinkage is noted will they keep escalating the dose until the criteria is met to be deemed MTD?
I know most of us on the board expect smooth sailing right thru all of Phase I but again I am simply playing devil's advocate in asking these questions should some unexpected results come about before the end of April.
Played golf yesterday with a buddy that has leukemia and he says his pills (1 per day) costs $8,000 per month.
Would like to thank seel in advance as she normally is very quick to provide technical information. Most valuable board member in my estimation.
