The Sort1+ PlatformThe points from JFM, Sabbo and Juniper are important and they really have to discuss this in reasonable depth once they get revised protocol approved. For them to pause enrollment and not outright stop it there must have been something in the totality of all the data collected and what others may know about PDCs, taxols and other dosign approaches to at least have some belief that they can use some part of the function they've observed to the benefit of efficacy. Maybe it's that half life issue that is advantageous in being able to dose more frequently and not take a 3 week pause in getting the chemo agent in to the tumor. I'm totally speculating, but that is the kind of disclosures they need to make to investors once they relaunch the trial. Give us the full logic --what was seen and why a different approach to get from only seeing 2-3 signs of efficacy to something more robust and how dosing is an element they can play with to try to get there. They need to explain to us the parts of the concept they "think" are valid and functioning enough in humans to theorize there should be efficacy with that type of chemo dosing regimin and why.
It's also encumbant that if they do think it's the chemo, that what they're seeing in their lab with other agents might lead to something more effective like what Sabbo and JFM are speculating on. If there is, that can be the basis for a partnership with someone who's taken those toxins further down the road and is looking for some way to target cells better. But they need to show that with data if it's there, which no one knows at this point. They've talked about SN38 and SiRNA so give any insights if there are any. That may be asking for too much, but the point of trying to validate the concept of the peptide and target would be valuable if there's any ability to actually do that from the data.
Last point, I think their trial is not a whole lot different than any other trial where you are trying to help the very late stage, heavily treated and resistant enrollees. All of those would face the same difficulties since it's just what happens at that stage unfortunately. I would assume there is always a mix of types of enrollees at the larger cancer centers in cities - some will try but end up deciding to stay at home with hospice and some will stay in centers doing everything they can to get through a trial. And you get everything in between. The unfortunate truth is there aren't many options left at that point and it would only be through a trial, and this is one of them some may try. I would think one advantage would be the side effects and safety issues have all been reported as still well below SAE3 levels. The issue is the robustness of the toxin doing it's thing on the tumors, not so much any treatment effects causing disenrollments. Anyway, it's incumbant on them to really explain it all in a reasonable depth so there can be a far better understanding based on that collected data and their reasonable theories on the restarted trial.
"If they treat patient with 1x docetaxel of TH1902 once weekly, the toxcity might be weaker and efficacy might be better."