This was in last weeks MSB Announcement Inflammatory Bowel...

This was in last weeks MSB Announcement Inflammatory Bowel Disease• The results of the first cohort of patients from the randomized, controlled study of remestemcel-L by direct endoscopic delivery to areas of inflammation in patients with medically refractory ulcerative colitis or Crohn’s colitis were presented at the 17th Congress of European Crohn’s and Colitis Organisation (ECCO) by the trial’s lead investigator Dr. Amy L. Lightner, Associate Professor of Surgery in the Department of Colon and Rectal Surgery at Cleveland Clinic• Results from an interim analysis of the first twelve patient cohort were published in the Journal of Crohn's and Colitis.2,3 A single local delivery of remestemcel-L by colonoscopy resulted in rapid mucosal healing, improved clinical and endoscopic scores as early as two weeks following remestemcel-L, and a high incidence of disease remission by six weeks. Dr. Lightner is scheduled to present results from additional patients at the world’s premier meeting for physicians, researchers and industry professionals in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery, Digestive Disease Week® (DDW) next month.



The FDA appear to be acknowledging our results too…

The draft on developing drugs for Crohn’s disease includes a new clarification, with the FDA explaining how traditionally, the Crohn’s Disease Activity Index (CDAI), a weighted index of 8 clinical and lab variables that estimate disease activity in CD, has been the most commonly used tool in pivotal CD trials.“However, the CDAI has been shown to be poorly associated with intestinal inflammation,” the draft says. “Given the limitations of the CDAI, FDA’s thinking on clinical endpoints for CD has evolved, and the recommended approach is to use coprimary endpoints to ensure that, in addition to relieving signs and symptoms, treatments have a meaningful impact on the underlying inflammation. Thus, coprimary endpoint assessment should include CDAI to evaluate signs and symptoms and an ileocolonoscopy to evaluate the impact of the drug on mucosal inflammatory changes.”




MSB using terms like ’rapid mucosal healing’ in last weeks Ann….