Is Saltikva safe?

Saltikva® is a genetically modified organism built on a Salmonella chassis, engineered for safety and to express human IL-2. The Phase 1 dose-escalation study was designed to test toxicity, and no dose-limiting toxicity was found up to the highest dose given (a single oral dose of 10¹⁰ cfu). In the Phase 1 and Phase 2 studies, no serious adverse event was ultimately attributed to Saltikva; one dehydration event first attributed to the study drug was later attributed to chemotherapy. The Phase 2, in which Saltikva was given with chemotherapy, recorded 41 serious adverse events overall. The Phase 2 enrolled a number of patients comparable to other Phase 2 studies in metastatic pancreatic cancer. Saltikva is investigational and has not been approved by the FDA or any other regulator.