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Takeda and TiGenix report positive data for Crohn’s disease therapy
Takeda and TiGenix have announced new clinical trial data showing the strong performance of their investigational compound Cx601 in the treatment of Crohn's disease.
The suspension of allogeneic adipose-derived stem cells was shown to help maintain long-term remission of treatment-refractory complex perianal fistulas in patients with Crohn's disease over a 52-week therapy period in the ADMIRE-CD trial.
Data from this phase III trial will help to support the companies' application for regulatory approval of the drug in Europe, with the European Commission having already granted Cx601 orphan drug designation.
A decision from the European Medicines Agency is expected at some point this year. Another phase III trial will also be launched in 2017 to help secure regulatory approval from the US Food and Drug Administration.
Dr Asit Parikh, head of Takeda's gastroenterology therapeutic area unit, said: "Existing therapies are limited and associated with complications and a high failure rate. Cx601 may offer patients an alternative treatment option."
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