TxCell Enrolls First Patient for Phase IIb Crohn’s Disease Study

TxCell Enrolls First Patient for Phase IIb Crohn’s Disease Study
TxCell SA, a biotechnology company specializing in developing novel immunotherapies for severe chronic inflammatory and autoimmune diseases, has just announced the enrollment and dosing of the first patient in the Phase IIb clinical study of Ovasave®, indicated for the treatment of refractory Crohn's disease. Ovasave® (ovalbumin-specific autologous Treg cells) is the company's lead product for this form of inflammatory bowel disease, and is currently approved for study in 6 European countries, with preliminary results expected by the end of 2016 to early 2017. Previously completed studies on Ovasave demonstrated a favorable tolerance profile and treatment response in 75 percent of patients, with 38 percent achieving remission after 5 weeks of treatment. The ongoing Phase IIb study, "CATS29" will be conducted in 32 study sites across Austria, Belgium, France, Germany, Italy and the United Kingdom, and aims to enroll 160 patients with severe refractory Crohn's disease. CATS29 will be evaluating treatment response rate for one intravenous dose of 1.10(6) cells of Ovasave, compared to a placebo 6 weeks following treatment. Response rate will be measured according to a decrease of at least 100 points in the Crohn's Disease Activity Index (CDAI). "The CATS29 study is a multicentre, randomised, double-blinded, placebo-controlled, multi-dose and multi-injection, 4 parallel groups study. It will evaluate the efficacy and the safety of Ovasave (ovalbumin-specific autologous Treg cells (Ova-Treg)) in patients with active refractory Crohn’s disease. Patients will receive, double-blinded, two intravenous (iv) injections 8 weeks apart of either 1.10(4), 1.10(6), or 1.10(7) cells of Ovasave or placebo. Patients will then receive either an open-label treatment with 2 additi
Subscribe or to access all post and page content.