The Food and Drug Administration (FDA) has granted the stem cell therapy Cx601 (TiGenix) orphan drug designation for the treatment of complex perianal fistulas in patients with Crohn’s disease.

Cx601 is a first-in-class allogeneic cell therapy intended for patients who have had an inadequate response to at least one conventional or biologic therapy. The company has already completed a Phase 3 trial (ADMIRE-CD) in Europe. The 24-week results were published in the journal, The Lancet, and showed that a significantly greater number of Cx601-treated patients achieved the primary endpoint of combined remission in the intent-to-treat group (53 of 107 [50%] vs 36 of 105 [34%]; P=0·024).

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A global Phase 3 clinical trial (ADMIRE-CD II) intended to support a future U.S. Biologic License Application (BLA) has been initiated. ADMIRE-CD II is a randomized, double-blind, placebo-controlled study designed to confirm the efficacy and safety of a single administration of Cx601 for the treatment of complex perianal fistulas in Crohn’s disease patients.

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