Takeda Acquires Rights to Cx601, Possible Stem Cell Therapy for Perianal Fistulas in Crohn’s Patients

Takeda Acquires Rights to Cx601, Possible Stem Cell Therapy for Perianal Fistulas in Crohn’s Patients
Takeda Pharmaceuticals has entered an exclusive licensing agreement with TiGenix to develop and commercialize Cx601 as a treatment for complex perianal fistulas in patients with Crohn’s disease. The agreement applies to Europe, specifically, where an application for the drug's approval has already been filed. Cx601 is a suspension of allogeneic adipose-derived stem cells (eASC) applied as an injection directly into lesions. Perianal fistulas are a serious and disabling complication of this intestinal disease and currently have no effective treatments. Because Crohn’s disease is considered an orphan disease – a condition affecting only a small percentage of the population – the European Commission designated Cx601 an orphan drug in 2009, speeding its development as a possible treatment of complex perianal fistulas. More recently, TiGenix filed a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) in March requesting its approval. The filing was based on the 24-week results from the ADMIRE-CD Phase 3 clinical trial sponsored by TiGenix. Trial results, announced in August 2015, showed Cx601 was significantly superior in inducing combined remission in treated Crohn's patients with complex perianal fistulas compared to a placebo. Specifically, 49.5% of treated patients achieved combined remission (the study's primary endpoint) at week 24 compared to 34.3% in the placebo arm. Efficacy results were consistent and robust, and treatment-related adverse
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