RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:POC in humans has been acheived is that it I would really caution that this is them just doing what responsible trial sponsors should do and putting out their complete data set. It doesn't point necessarily to any meaningful advancement of the program. That may be under-selling the actual data content but it seems like a reasonable guess to me.
scarlet1967 wrote: To me it seems like they are trying to link the new optimized dosing and its results with previous trial/trial's results. There is still a part 4 for this new trial design. Could they alter it again and go straight to phase2 based on sufficient data? I believe so!
Mannequin wrote: It seems to me that maybe they have seen something but really have not been able to properly isolate the dose and they are fine tuning it. Is this number of patients enough to get into a Ph2
scarlet1967 wrote:
Just wanted to clarify the fact that 300mg/m2 is the higher dose level in part 3 of phase1(the second group of the patients will be dosed at that level)! Therefore what ever this new presentation will be revealing almost will be relevant as the dosage is (despite the different intervals, weekly versus previously every 3 weeks) similar to the ongoing clinical trial.
"The amended study will be a modified 6+6 design with two different dosing regimens that are within the efficacious range for sudocetaxel zendusortide: 1.75 mg/kg on days 1, 8, and 15 of a 28-day cycle (similar to 210 mg/m2 every 3 weeks) and 2.5 mg/kg on the same schedule (similar to 300 mg/m2 every 3 weeks)."
Hopefully with this more frequently dosing they will be better off in terms of both safety and efficacy of the drug.