TxCell starts cell therapy trial in Crohn’s patients
France-based TxCell SA has enrolled the first patient in a new trial of its cell therapy for Crohn’s disease which aims to demonstrate that 160 patients with refractory disease can experience relief. Crohn’s is an inflammatory bowel disease affecting the gastrointestinal tract.
France-based TxCell SA has enrolled the first patient in a new trial of its cell therapy for Crohn’s disease which aims to demonstrate that 160 patients with refractory disease can experience relief. Crohn’s is an inflammatory bowel disease affecting the gastrointestinal tract.
The primary endpoint of the Phase 2b study, named CATS29, is to achieve a response to the therapy six weeks after a single intravenous injection. Response is defined as a decrease greater than or equal to 100 points in the Crohn’s Disease Activity Index. In the trial the cell therapy will be compared with a placebo.
An earlier clinical study in patients with refractory disease had a positive efficacy outcome and the therapy was well tolerated, according to the company.
The therapy, Ovasave, is a T cell immunotherapy that uses antigen specific regulatory T cells. Upon administration, the cells go to the site of inflammation where they are thought to be activated by the specific antigen. The cells then release immune suppressive factors, cell-to-cell contacts, and cytotoxic activity to treat the inflammation. Ovasave has been classified as an Advanced Therapy Medicinal Product by the European Medicines Agency.
Top-line results from the Phase 2b study are expected at the end of 2016 or early in 2017.
TxCell announced the start of the study on 4 December 2014.
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