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Ann: First Patient Dosed in VAXINIA Intravenous Cohort 2, page-11

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  1. 6,765 Posts.
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    "Once patients in the monotherapy group have been treated with the lowest doses of VAXINIA and acceptable safety has been demonstrated, new study participants will receive combination treatment, CF33-hNIS with the immunotherapy pembrolizumab. This is expected to begin following cohort 2 being cleared per route of administration. Overall, the study aims to recruit up to 100 patients across approximately 10 trial sites in the United States and Australia."

    I am bit confused with the above 'bold' bit of the announcement. I thought convention is to finish PH1 to determine optimal dose and safety of Vaxinia. And then proceed with whatever combo plan. But here, it seems like after this Cohort 2 is done, new patients will go straight into combo with Keytruda.

    Is that a hint that even with the very low dose Cohort 1, it should be good enough dose from what they seen? And that this Cohort 2 higher dose should be the optimal dose already if it is proven safe as well? Otherwise, surely they won't go into combo without knowledge of optimal dosage, right?
    Last edited by fattchoi: 05/12/22
 
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