RE:Any comments on this from Leede's Doug Loe? I think basically he's pointing to the facts that Wino, Juniper and others have made. That if SORT1 can vacuum up more of the drug than would passively enter the cell in it's naked docetaxel form then 300 is still potentially a very potent dose. I think that's what the sentence starting "Accordingly" is referring to.
He seems pretty forthright about the tolerability of the drug at 420 with that "(barely)" comment. It's probably up to the company to give details on those AEs so we are more certain these side effects do just match those seen with normal docetaxel. If these AEs really do match docetaxel's profile I think I would be a bit more relaxed about them, if they represent something new then there's a little more uncertainty.
"ascribe formal market value to this program will be forthcoming" - super positive
SPCEO is this just the summary? Is there more detail about TH1902? Also what's his take on sales?
SPCEO1 wrote: Thera provided an update on its Phase I solid tumor testing with TH-1902, indicating that it has likely identified a maximum (barely) tolerable dose that is at or above 420 mg per square meter of body surface area, and this observation motivated the decision to shift all future patient dosing to a lower level of 300 mg/m2. Thera indicated that this represents a 1.5x elevated dosing level over that commonly used for docetaxel itself in solid tumor chemotherapy, but in our review of the literature, it is far higher than that (docetaxel as a monotherapy tends to be administered initially in most tumor types at 75-to-100 mg/m2). Accordingly, we believe that dosing at or above 300 mg/m2 still reflects favorably on the tumor targeting pharmacology that conjugation to sortilin receptor-binding peptides confers in TH-1902. As stated above, the concept of incorporating sortilin biochemistry into TH-1902 for targeted chemotherapy still seems reasonable to us and we are optimistic that justification for us to ascribe formal market value to this program will be forthcoming.