TiGenix Starts Global Phase 3 Trial to Evaluate Cx601 as a Treatment for Crohn’s Fistulas

TiGenix Starts Global Phase 3 Trial to Evaluate Cx601 as a Treatment for Crohn’s Fistulas
TiGenix has started a pivotal Phase 3 clinical trial of Cx601's ability to treat a complication of Crohn’s disease known as complex perianal fistulas. Fistulas are sores between the end of the bowel and the skin near the anus. Cx601 uses stem cells to treat them after other therapies have failed. Fistulas can cause bleeding and discharge when defecating, and can be painful. Previous clinical trials, including the Phase 3 ADMIRE-CD (NCT01541579) study, showed that Cx601 was able to eliminate fistulas that other therapies could not. The trials also showed Cx601 to be safe. The new global study is designed to confirm the effectiveness and safety of a single administration of Cx601 as a treatment for fistulas. TiGenix hopes the results are good enough for it to submit a Biologic License Application for Cx601 to the U.S. Food and Drug Administration. The company announced the new trial after convening its first meeting of European clinical trial investigators in Rome, June 8 and 9. The meeting brought together more than 60 gastroenterologists, colorectal surgeons and study coordinators from 30 trial sites across the European Union. TiGenix plans similar meetings in other European countries, the United States, Canada and Israel, starting later this year. “Investigator meetings are critical to the success of any clinical trial," Marie-Paule Richard, TiGenix's chief medical officer, said in a press release. "The
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