AsianScientist (Aug. 11, 2016) – Takeda Pharmaceutical and cell therapy company TiGenix have announced the 24-week results of a Phase III ADMIRE-CD trial investigating Cx601, a stem cell treatment for complex perianal fistulas in patients with Crohn’s disease. These results have been published in The Lancet.
Crohn’s disease is a chronic inflammatory disease of the gastrointestinal tract that affects approximately five million patients worldwide. Cx601 is meant to treat patients with an inadequate response to at least one conventional or biologic therapy. Recognizing the debilitating nature of the disorder and the lack of treatment options, in 2009 the European Commission granted Cx601 orphan designation.
The results of this Phase III trial showed that a significantly greater proportion of patients in the Cx601 group versus the placebo group achieved the primary endpoint of combined remission at week 24. These results were confirmed in the per-protocol population and in additional supportive and sensitivity analyses.
TiGenix also recently announced 52-week data indicating the potential for efficacy and safety of a single treatment of Cx601 are maintained during a year of follow up.
A pivotal Phase III trial for Cx601 for the treatment of complex perianal fistulas is expected to start in the US in 2017.
The article can be found at: Panés et al. (2016) Expanded Allogeneic Adipose-Derived Mesenchymal Stem Cells (Cx601) for Complex Perianal Fistulas in Crohn’s Disease: a Phase III Randomized, Double-blind Controlled Trial.
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