FDA Accepts TxCell’s IND Application To Treat Refractory Crohn’s Disease

FDA Accepts TxCell’s IND Application To Treat Refractory Crohn’s Disease
TxCell SA is a biotechnology firm advancing innovative and personalized T cell immunotherapies utilizing antigen specific regulatory T-cells (Ag-Tregs) to address both severe chronic inflammatory and autoimmune diseases. The company recently announced that the United States Food and Drug Administration (FDA) has accepted TxCell’s Investigational New Drug (IND) application for Ovasave(R), the company’s lead product that is currently in phase 2b to address patients suffering with refractory Crohn’s disease. This is one of largest studies ever conducted for a personalized T-cell immunotherapy product. The activation of the IND allows TxCell to extend the CATS29 project to the United States. The CATS29 study has currently been ongoing in Europe since late December. There are 30 study locations currently operating the project in 6 countries in the European Union. It has been thought to enroll 160 patients affected with severe refractory Crohn’s disease. The extension of this work to the United States sites could start in the first half of 2016. “This active US IND is a very important milestone for TxCell as it is the first ever obtained by the Company with one of its products. It is a sign of maturity for TxCell and, importantly, for its cellular immunotherapy technology based on regulatory T cells products, a field in which our Company is a pioneer and a world leader,” said Stéphane Boissel, TxCell's CEO. Miguel Forte, TxCell's Chief Operating Officer,
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