No free docetaxol - seeing the same in humans as we say in preclinical. There's that very clear statement.
Wino115 wrote:Need to look at that slide again but appears they are now up to that 2x normal dosage level (420) after the SAE 2 and need to get 3 patients at that level with no DLT to move to the next one that is 30% more drug. It seems they've gotten there with minimal patients (9) which while that sounds slow, actually means they've been able to move up each level with just one patient because there was no SAEs. In other words, they haven't had to use that 3 patient level until this 420 level. So that's actually good.
It did appear he's talking down any efficacy signs and I can understand why now. They may actually get to the DLT or their targeted level with 15 or less patients. The good is that this means they didn't have a lot of SAEs setting them back such that they needed to move ahead with the 3 patient levels and have moved quickly into those high dose levels. The bad is they got there with so few SAEs that they used the minimum number of patients. The range was 15 to 25 and looks like they'll be closer to the 15. Obviously this means they wont' have a lot of a population to monitor for efficacy but I would guess the ones from 1.5x on they are scanning and getting that. Seems they'll hit that MTD soon though. It may actually be literally end of year if they go up one more level though and his mentioning end 21/early22 seemed to incorporate if they decide to take it up one more level or maybe even two more levels. So while not getting a year end update is a negative, it means they would be seeing a huge, huge dose that would increaes efficacy even more. That's my quick read.