RE:RE:MTD and the FDA I wasn't suggesting wrench throwing and you're right this is about the therapeutic window and the space in which thtx can play with this drug. Things like that are as important as getting a strong indication of efficacy at this point in the process.
Even though the fda is exploring alternatives MTD is still the benchmark.
I was mostly just trying to plug my old, general idea that the presence of docetaxel is great for the drug development process. Most of this is technical and as investors we should just leave that to the thtx team, it's just my pre-occupation.
Wino115 wrote:
It could be why they added in a few months to the Phase2 timeline. I think you're right about the advantage of a known toxin. If you have safety all the way to your chosen MTD ( like Kuras Menin-inhibitor) and a wide therapeutic window as THTX has suggested, then maybe you explore high/low dose. The Menin-Inhibitors are new so that's valuable. Docetaxel in tumors is old and they probably know how to use it with low vs high dose like you say. But whatever the FDA works out for TH1902, it shouldn't be throwing a wrench in the works. Add a few more patients to each of the 4 tumors and do a low (or normal taxel equivalent) and MTD. On the other hand, since the normal therapeutic dose of taxel is below where they are, they know a lot about the low dose environment, although not delivered via SORT1.
qwerty22 wrote: Scarlett brought this news to the board about the fda seeking alternatives to MTD.
https://www.fiercebiotech.com/biotech/fda-s-renewed-focus-oncology-dosing-spooks-investors-but-companies-say-they-were-ready It got me thinking about how thtx might handle this (if they had to), I'm not suggesting they have to atm. Anyway it's pretty well known how normal docetaxel accumulates in tumours. You can use that concentration as your target concentration for dosing. So rather than rely on MTD to find the maximum dose based on safety you use a tumour accumulation number to get a dose based on efficacy. You can only do this because you have the long experience of using docetaxel in patients. I'm not saying this is what they'll do, to me it's just another example of how it might help the drug development process to be using an old, well-understood chemo.
Hopefully they get tumour material and are able to measure drug (and released docetaxel) in the tumour. It will be a good number to have for many reasons. If investors were truly spooked by the FDA's shift from MTD, it would be good for thtx to have a pre-prepared solution.