RE:RE:Credit Suisse event now availableI came up with some ideas why there might not be any efficacy signals. Please let me know it this makes any sense, and feel free to poke any holes in my logic.
1) There have been no high sortilin expressing patients so far. (seems unlikely as sortilin is more expressed as the disease progresses.)
2) TH1902 does not enter into the sortilin expressed cells. This could be because sortilin expressing cancer cells might be deeper in the tumor surrounded by a layer of non-expressing cancer cells.
3) TH1902 does enter the sortilin expressing cancer cells but the taxol is not cleaved.
4) TH1902 does enter the sortilin expressing cancer cell and the taxol is cleaved but is not effective against these particular cancer cells.
@qwerty22, please let me know your thoughts.
qwerty22 wrote: So it's pretty clear now that the part1 protocol is different to the way they previously presented it (Scarlett was bang on). So enrolment numbers are still very low. I think I'm a little more comfortable about there being no efficacy signal so far. Once you combine the low patient numbers, all-comers, low doses and super sick people then it's perfectly acceptable to not have a signal so far. The pain for us has been the time it has taken to get to this point, I think the impression was we'd get to this point faster than we actually have. So for me the good news is they have gotten to this point in as good a shape as you might expect from a safety perspective and if there is going to be a first sign of efficacy then is was probably always weighted to happen from this point forward so the lack of efficacy so far is not too much of an indicator of what might happen in the weeks/months to come.
Like SPCEO I wish they'd be more open about some of the things they've seen in the patients so far. If they are presenting the mouse data for drug breakdown in the blood. And they say they have early human data for that as well and both align. Why not flesh that out a little. If the amount of free docetaxel is very low then some sort of provisional peak number would be super encouraging.
I think I parse Paul's positivity as arriving at this point is the trial in as good a shape as you might hope for. The potential for efficacy (if it's coming) is still ahead of us.
Along the lines of SPCEO's grading it's -
B- for the state of play so far (it would be higher is they shared more actual human data)
D for the length of time it took to get here.
Just on NASH
Sounds to me like time (and waiting) is going to be another important factor in advancing NASH P3. I don't expect anything until later in 2022. Sounds like they are seeing many in the NASH space are in a wait and see mode. If the wait drags on it won't simply be due to the internal strengths/weaknessses of the program alone.
palinc2000 wrote: Under event tab at Thtx website