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They ran a Phase I safety study of rectally administered BPC-157 and a randomized, double-blind, placebo-controlled Phase II enema study in ulcerative colitis

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The approval is supported by data from the Phase III NRG-GY018/ KEYNOTE-868 trial, in which the regimen reduced the risk of disease progression or death by 40% in patients whose cancer was mismatch repair proficient and by 70% in patients whose cancer was mismatch repair deficient, when compared to placebo with carboplatin and paclitaxel followed by placebo alone