Key results of the interim analysis performed in the first 12...

Key results of the interim analysis performed in the first 12 enrolled patientswere as follows:•Colonoscopic delivery of remestemcel-L was not associated with any treatment-related adverse events •All ulcerative colitis patients treated with remestemcel-L had improved clinical and endoscopy scores within two weeks, as defined by the Mayo clinical score and Mayo endoscopic severity(MES)score, and all achieved clinical and endoscopic remission by six weeks •Allulcerative colitis patients were extremely satisfied or satisfied with remestemcel-Ltreatment at three months, based on the inflammatory boweldisease patient reported treatment impact (IBD-PRTI),and response was described as excellent or good in all patients•All Crohn’s colitis patients treated with remestemcel-L showed treatment remissions or responses by three months, as measured by the Simple Endoscopy Score for Crohn’s Disease (SES-CD) (mean score 17 at baseline decreased to 5at three months) •Remestemcel-L treatment resulted in reduction of fecal calprotectin, a validated biomarker of disease activity,5from mean of 231 at baseline to 67 at three months, indicative of remission•In controls with ulcerative colitis and Crohn’s colitis over three months, endoscopy scores increased, fecal calprotectin levels increasedfrom a mean of 330 to 505, and clinical responseswere described as poor or unchanged
Key results of the interim analysis performed in the first 12 enrolled patientswere as follows:•Colonoscopic delivery of remestemcel-L was not associated with any treatment-related adverse events •All ulcerative colitis patients treated with remestemcel-L had improved clinical and endoscopy scores within two weeks, as defined by the Mayo clinical score and Mayo endoscopic severity(MES)score, and all achieved clinical and endoscopic remission by six weeks •Allulcerative colitis patients were extremely satisfied or satisfied with remestemcel-Ltreatment at three months, based on the inflammatory boweldisease patient reported treatment impact (IBD-PRTI),and response was described as excellent or good in all patients•All Crohn’s colitis patients treated with remestemcel-L showed treatment remissions or responses by three months, as measured by the Simple Endoscopy Score for Crohn’s Disease (SES-CD) (mean score 17 at baseline decreased to 5at three months) •Remestemcel-L treatment resulted in reduction of fecal calprotectin, a validated biomarker of disease activity,5from mean of 231 at baseline to 67 at three months, indicative of remission•In controls with ulcerative colitis and Crohn’s colitis over three months, endoscopy scores increased, fecal calprotectin levels increasedfrom a mean of 330 to 505, and clinical responseswere described as poor or unchanged

Hi DaChopper,
Yes that was the same trial, not sure how 19 patients became 18.
Excited by the results as this was not Rem-l but they did use bone marrow derived msc's.
Convinced the early results announced at ECCO will be repeated.

A question for the group- if Rem-l is demonstrating efficacy in the Chrons and UC RCT , can these results be used to sway the FDA about off the shelf potency for aGvHD?


Reg