TxCell announces start of phase IIb clinical trial with Ovasave for refractory Crohn’s disease

05-Dec-2014 - France

TxCell SA announced that it has enrolled the first patient in its phase IIb clinical trial of its lead product Ovasave(R) in refractory Crohn’s disease. TxCell has received approval for this multi-center, multinational trial from the regulatory authorities in all six European countries in which the trial will be performed. Top line results of this study are expected at the end of 2016 to early 2017.

The phase IIb study, named CATS29 (Crohn’s And Treg Study) includes 32 study sites in 6 countries (Austria, Belgium, France, Germany, Italy and United Kingdom). The trial has been designed to include 160 severe refractory Crohn’s disease patients.

The primary objective of the CATS29 study is the evaluation of the response rate for a single intravenous injection of 1.10(6) cells dose of Ovasave compared to placebo 6 weeks post administration. Response is defined as a decrease greater than or equal to 100 points in the Crohn’s Disease Activity Index (CDAI), the gold standard regulatory measure of response in Crohn’s disease.

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