BIO-Europe Spring® 2016: TxCell plans U.S. studies in Crohn's after addressing manufacturing issues
TxCell SA CEO Stéphane Boissel tells Pharma Intelligence Senior Editor Sten Stovall why the French cell therapy company is exploring the therapeutic potential of regulatory T-cells (Tregs) in large-scale studies and extending its Phase IIb clinical study to the US using a recently granted IND. Lead product Ovasave is being evaluated in a Phase IIb study, CATS29, in Europe, involving 30 medical centers in six countries and 160 severe refractory Crohn’s disease patients, which is expected to be completed in 2017. When GMP-manufactured product is available, the study will be extended to the US, Boissel says. The product is being positioned as the last option for younger patients, aged around 35 years, who have Crohn’s disease that is refractory to all other therapies including steroids, immunosuppressives and anti-TNFs, and have no medical options left.