TiGenix Lead Compound Cx601 Efficient in Treating CD Patients’ Perianal Fistulas

TiGenix Lead Compound Cx601 Efficient in Treating CD Patients’ Perianal Fistulas
TiGenix, a leading biopharmaceutical company developing therapeutics based on adult stem cells, recently announced the results of the Phase III ADMIRE-CD clinical trial, testing the company's lead compound Cx601 on Crohn's disease patients with complex perianal fistulas. Crohn's disease is a type of inflammatory bowel disease (IBD) and is characterized by inflammation of the digestive tract, with inflammation being triggered in any location from mouth to anus. Crohn's disease patients can develop perianal fistulas (about 25% of all CD patients), which are associated with local pain but are also a cause of morbidity (including by sphincter and perineal tissue destruction) and for which no currently effective treatment is available. The Phase III ADMIRE-CD trial investigated Cx601's efficacy and safety when administered as a single injection in Crohn's disease patients. The treatment (Cx601) consists of injecting previously allogeneic expanded adipose-derived stem cells, eASC, (i.e. stem cells derived from adipose tissue of a donor, and not derived from patients themselves) directly into the lesions. The randomized, double blind, placebo-controlled Phase III ADMIRE-CD trial enrolled 289 Crohn’s disease patients who failed to respond to previous treatments (including those treated with anti-TNF therapies). Patients were recruited within European countries and Israel and were randomly assigned to receive either a single injection of Cx601 or a placebo control. The study's primary endpoint was defined as closure of all treated external openings draining at baseline within 24 weeks of treatment with lack of collections
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