What did the Phase 1 trial of Saltikva show?

Q: What did the Phase 1 trial of Saltikva show?

The University of Minnesota Phase 1 of Saltikva ( NCT01099631 ), run from 2010 to 2014, gave 22 patients with metastatic gastrointestinal cancers that had spread to the liver a single oral dose, from 10⁵ to 10¹⁰ CFU, to learn about tolerability. There was no dose-limiting toxicity, and blood NK and NK-T cells rose afterwards. Two patients had events judged possibly attributable to the bacterium and recovered, and 8 of the 22 patients did not complete the study. The paper reports no tumor responses and no survival advantage from a single dose, and the authors recommended a multiple-dose study.

Question

Accepted Answer

The University of Minnesota Phase 1 of Saltikva (NCT01099631), run from 2010 to 2014, gave 22 patients with metastatic gastrointestinal cancers that had spread to the liver a single oral dose, from 10⁵ to 10¹⁰ CFU, to learn about tolerability. There was no dose-limiting toxicity, and blood NK and NK-T cells rose afterwards. Two patients had events judged possibly attributable to the bacterium and recovered, and 8 of the 22 patients did not complete the study. The paper reports no tumor responses and no survival advantage from a single dose, and the authors recommended a multiple-dose study.