Most Crohn’s Fistulas Are Still Gone a Year After Cx601 Treatment, Trial Shows

Most Crohn’s Fistulas Are Still Gone a Year After Cx601 Treatment, Trial Shows
TiGenix’s Cx601 was able to resolve a painful Crohn's disease condition known as complex perianal fistulas for a year, according to a Phase 3 trial. Only a quarter of the patients whose condition was resolved within 24 weeks of the treatment had it recur by week 52, researchers said. That compared with 44.1 percent recurrence in a group treated with a placebo. An anal fistula is a small channel that can develop between the end of the bowel and the skin near the anus. It can cause bleeding and discharge when defecating, and can be painful. TiGenix will present the results of the ADMIRE-CD Phase 3 clinical trial (NCT01541579) at the Digestive Disease Week (DDW) annual meeting in Chicago, May 6-9. The presentation will be entitled “Cx601, Allogeneic Expanded Adipose-Derived Mesenchymal Stem Cells (eASC), For Complex Perianal Fistulas In Crohn's Disease: Long-Term Results From A Phase III Randomized Controlled Trial.” Professor Julian Panés, head of the Gastroenterology Department at the Hospital Clinic of Barcelona, will deliver the presentation. He is also president of the European Crohn's and Colitis Organization. Cx601 closed all external openings that had been draining at the beginning of the clinical trial, according to interim results. Researchers confirmed the absence of perianal fistulas after treatment with magnetic resonance imaging (MRI). Seventy of the 105 patients treated with Cx601 stayed in the trial until the follow-up period ended at week 52. The most common adverse events of the therapy were anal abscesses, or sores, and proctalgia, or pain in the rectum and anus area. Still, the frequency of the events was similar between the treatment and placebo groups. "We are delighted that the positive 52-week results from the AD
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