RE: Next Weeks Shocker17 Feb 2023 14:11
Except that a DE to, say, 240mg/m², which is equivalent to 162mg/m² doxorubicin equivalent would only allow two cycles (from a starting point of no prior doxorubicin) to keep under the 450mg/m² CTLD, if indeed 450 is the limit, and they surely want to be going even higher if the intention is to find MTD - "higher dose cohortS" plural.
I just don't think it is possible/useful to escalate the dose within the constraint of doxorubicin's traditional CTLD. And, speaking personally, if I wanted to up the allowable CTLD of AVA6000-delivered doxorubicin I'd also want to increase the frequency of administration (shorten the cycle time) as the body doesn't need the 3 weeks to recover from doxorubicin-indiuced side-effects.
Such changes would need to go to MHRA, FDA and their respective ethics committees, and that takes time. If the starting gun for this was back in November/early December, then a decision is surely due soon (expected by Avacta by Science Day?) according to the FDA (at least) 30 day or 60 day or whatever it is time limit for responding.