Just my thoughts on updates, if the trials are held at multiple centers and IMU sets the criteria for acceptance and exclusion as outlined in there poster some 20 all up of both inclusion and exclusion criteria add to this i assume the selection criteria would change as the trial progresses and new information is gained. In the early trials as outlined in a poster presentation, is that there were Responders and Non Responders, :IE those who showed little response to Vaxinia, responders showed higher frequency of T cells. So given that and the opportunity to increase each cohort up to 20 patients as shown below cut from poster. With all this going on at different centers it would be very difficult to say exactly when it is time to do a data cut. Given they don't know when enrollments will take place and then how they respond. Given this is a dose escalation trial you can be assured that as information comes in about each cohort enrolment in the next cohort will have a new set of criteria for inclusion in the effort to achieve the best Reponses.
In this early poster it covered seven patients in the IT mono therapy and had the CR and Sd patients in it. It said the responders was 3 and non responders 4 so more Non responders. I am sure they would be looking at why? Then trying to get more responders in each arm of the trial.
Anyway just some weekend thoughts to ponder.
Number of patients
• During the dose-escalation phase, up to 6 evaluable patients will be treated in each
cohort per route of administration (IVand IT) and treatment regimen (monotherapy
and combination).
• Once a monotherapy or combination cohort has been cleared to obtain additional
safety and efficacy information, the number of patients in that cohort may be expanded
to a total of 20 patients with CRC agreement.
• In total, up to 150 patients will be enrolled
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