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, added: “The receipt of the IND for the CATS29 study with Ovasave from the FDA will give TxCell an option to extend the trial in the US. The extension to this trial, already one of largest ever-controlled studies for a personalized T cell immunotherapy product, could give additional resources, namely in terms of patient recruitment, to accelerate the study. The IND provides further opportunities for Ovasave to progress smoothly and rapidly to phase 3 and commercialization. It also opens the possibility to assess the benefit of our antigen specific T regulatory cell therapy in refractory Crohn’s disease patients who have no alternative treatment options, from US sites.”
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