I know its early and 6 CLL patients is too few to judge
Hi jaybe,
I don't want to speak for Doug, but it's my understanding that it's often takes several cycles(unlike some anti CD-20s) to show efficacy with PI3K inhibitors, so 67% for a Jan readout seems fine for the moment, because I think we can assume that the efficacy will only improve with time.
In addition, since PI3Ks are all likely to have their major value in combos, when the ceo recently confirmed that efficacy continues to improve with time, but more importantly, that TGR-1202, (as of the recent Qtr call), continues to show no signs of liver or any other unmanageable toxicity, I think that's a lot more important. This is after all a dose escalation study, so max efficacy doesn't usually materialize at the outset.
In other words, if TG-1202 does what it was presumably designed to do(to avoid liver toxicity by eliminating certain aspects of previous PI3K chemical structures associated with toxicity), then it's efficacy should increase nicely with the 3-4 fold formulation and administration advantages recently identified, and the lack of toxicity issue will be a critical advantage.
Although I agree that this is yet to be demonstrated, I think the absence of any liver tox to date is very encouraging in this class of drugs.
But I agree with Doug-I appreciate you looking into tgtx and please advise us of any reservations you may have.
Best,
bw