What human evidence exists for the mechanism of Saltikva?

In the Phase 1 trial of Saltikva (22 patients with metastatic gastrointestinal cancers, single oral doses from 10⁵ to 10¹⁰ CFU, no dose-limiting toxicity), mean peripheral natural killer cells rose from 12.1 to 14.6 percent and NK-T cells from 3.4 to 5.6 percent five weeks after a single oral dose (p=0.02 for each), with no dose dependence. In the Phase 2 paper, immune profiling was done only in the first treated patient, and direct confirmation of intratumoral colonization and localized IL-2 release was not performed. Human tumor colonization by Saltikva therefore has not been demonstrated.