RE: Trial Design17 Aug 2022 00:19
Hi Stakis, I will try to answer your question as best I can.
The trial can only start with 1, 2 or 3 patients who sign up knowing that this drug has never been tested in a human being. They are both poorly and very very brave. The trial is designed to go slowly at first so any adverse effects only affect the minimum of patients. Once these safety protocols are passed and proven to be, indeed safe, more patients are allowed to join the trial.
That is what happened today, the Trial moved cautiously forward bring in a further 3 patients in to become Cohort 2.
The ModiFY trial has just three clinical centres open to do the Safety / Toxicology part of the trial, in two months time if we have another RNS saying that Cohort 2 has passed the Safety protocol all the other recruitment sites ( 20 in total ) will then be able to join the trial and not before.
Lastly, from the quality and number of cancer centres wanting to be part of our Trial you can surmise that there are many patients willing and ready to be enrolled if they meet the correct criteria.
I hope that answers your question and helps pacify your concerns.
Chester.