RE:RE:“Low dose docetaxel”I am of the opinion that the SP can still rise ahead of trial results if oncology experts weigh in when they see enough signs that there is a chance of positive results...We have not seen that yet,,,,If that happens the SP will rise with no news
palinc2000 wrote: I dont know why some are expecting great news coming out of a Quarterly CC...They will provide some updates but no trial results on Thursday ..Any trial results would be released separately ahead of or subsequent to a Quarterly Financial Release.
I think it is fair to say that most early trials show some positive signs but those signs need to be confirmed by hard data ....There is a lot of talk about POC but whatever definition you use the confirmation that they are proceeding to Phase 2 will mean that POC has been reached
How much longer for that determination ? Not days imo maybe weeks byt probably months ....
qwerty22 wrote: So I went back to an idea I had when the 1a info was released regarding the issue with free docetaxel from the small portion of degraded drug. Can't believe it took me this long to google "low dose docetaxel" tbh. Anyway there's been preclinical and clinical work in this area. One study stands out. It uses 20mg/mm3 weekly for 3 weeks only in a palliative setting. I don't think they are bothering with scanning tumours at this stage. It uses PSA as a biomarker response and is looking at QoL issues for peoples final months. They report close to 50% see a reduction in PSA and there's an improvement in QoL, there was some duration to these response (mean 5 months). That's pointing to biological activity at low doses, this was in patients who'd already failed all options. I think generally there is less free Docetaxel in THTX's patients than these studies but it can't be ruled out that there's some effect here, both the PSA and even the prolonged Stable Disease patients might at least fall into this category. IDK about the 50% tumour reduction patient.
I'm back to worrying about the role of the "free docetaxel" in THTX's patients. Going with JFM's point that they've given us a headline piece of info on % degraded drug which is difficult to put into context, we need drug exposure numbers, it's difficult to say what role the free docetaxel is playing. The 50% tumour reduction seems robust, shame that patient dropped out for other reasons.
I guess the point I'm making is they need something more robust coming from 1b to show this drug is raising it's head above the backgroun$ noise you might see. Initially I thought one strength of this trial is it's a one drug trial, now we really need to at least rule in the idea that this is in fact a combo trial of th1902 and very low dose docetaxel. They can't just dribble out the odd PR patient and PSA responder and expect it to move the story along. So they have to hit milestones like whatever the nex5 go/no-go signal is. Probably no point in releasing news unless it reaches a particular benchmark.
https://pubmed.ncbi.nlm.nih.gov/12759524/ Maybe this is more nailing for me why they are still far from calling PoC atm, lot's of uncertainties still here. I'm not against SPCEO's calling a lot of positive signs but still something to prove.