RE: Bein, JT….24 Feb 2023 20:11
Just in gym Rip. Started reading, more tonight.
Trial protocol;
Dox concentration is measured by systemic exposure to cleaved dox. HUGE news. Trial design is OK.
Safety data;
Difficult to assess fully due to low data points, but it’s pretty much in line with other pro drugs. Nothing extraordinary. It’s quite rightly described as ‘modest’. That said, the profile is not the bottleneck here.
PKs;
Would like to see some data points. Shame, but understand as mid trial.
AUC - although stated as 60-90%. Great. In line with preclin.
Cmax - again, stated as 80-90% reduction. Fantastic.
Cl - would like to see clearance data.
The above is inline with other prodrugs delivering dox.
Biopsy data;
Fantastic and the main USP. Numbers are very good. Other prodrugs have similar PK performance, but MAY not clip the dox and grab hold of it at the tumour. This does. It’s clearly very effective.
Quick view; more later. Open to correction as always.