Belgian firm TiGenix (EXT: TIG) said Cx601, its lead candidate to treat Crohn's disease, has met its primary endpoint in late stage trials.
The cell therapy company said the study results confirm the favorable safety and tolerability profile of Cx601 adding that the data allows for European regulatory filing in the first quarter of 2016 and paves the way for moving forward in the US.
Marie Paule Richard, chief medical officer of TiGenix, said: "We are extremely excited about the results of Cx601 in this severely debilitating and difficult to treat condition. Achieving more than 50% combined remission in patients who have not responded adequately to previous treatments, including anti-TNFs, is a remarkable accomplishment."
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