"My analysis may indeed be incorrect, so any comments from the scientists, mathematicians or medico's among us on the trial, dosage rates or anticipated outcomes, would be appreciated."
Thanks Ben, for your post and ongoing quality contributions to these threads.
The recent poster presentation at SITC 2023 released on 6th November 2023 provided an excellent insight into the Dose Escalation Scheme for the Vaxinia MAST trial.
A Phase I Safety and Tolerability Study of VAXINIA (CF33-hNIS), a Novel Chimeric Oncolytic Poxvirus, Administered Intratumorally or Intravenously in Adults with Metastatic or Advanced Solid Tumors.
https://static1.squarespace.com/sta...99224552384/SITC MAST TIP_final 14Oct2023.pdf
In this presentation we saw the initial 16 cohort design be expanded to 26 cohorts with a dose escalation in both IT and IV for monotherapy and combination to extend to 3x10^9 i.e. (3 billion virus particles). The plan is now to test up to 150 patients in this expanded design.
It is worth noting that as cohorts progress through the therapeutic index they are dosed at 1x and 3x for each log of the index.
The graphic below from the poster presentation has now been updated by the recent announcement on 2nd November - Cohort 5 of the IV arm for the monotherapy dose escalation is now open as is IV cohort 3 of the combination study.
So yes, very exciting times indeed as we wait for the next data readout of the MAST trial.
I am looking forward to the day when the primary end points of this study are released, and the esteemed Professor Yuman Fong can release the news to the world with thunderous acclaim and deserved applause that he has indeed claimed the holy grail.
GLTAH - Go Team Imugene
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