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Ann: First patient dosed in Phase 1 bile tract cancer trial, page-46

  1. 2,888 Posts.
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    Yup - correct friend @reon1

    They will now be dosing at 1 x 109 or 1 billion PFU. I asssssume that's also what they will be using for the Colangio expansion group.

    This announcement cement tells us that Vaxinia is maintaining its excellent safety and tolerability - or they would not have progressed beyond 3 x 108 (300 million PFU).

    It also tells us that the immune response/clinical benefit for the recently completed 3 x 108 cohort showed a significant improvement over the preceding dose of 1 x 108 - because if it had not done so then the OBD would have been declared at that lower 1 x 108 dose level.

    So my take away from this is: the trial is progressing well. Vaxinia is safe, even at high dosage levels, and the data (when we get to see it) will show that Vaxinia does indeed work better at higher dose levels than at lower.

    If one billion PFU produces no significant safety and tolerability issues - AND if it shows further improved clinical effect (compared to 300 million PFU) - then this may become the OBD. Of course it's also possible that the immune response/clinical benefit will level out at this point - in which case they would revert to 300m PFU as the OBD.

    It all takes time, but I'm very happy with today's news.

    Cheers

    Dave

 
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