TiGenix’s study of Cx601 showed that results after two years are consistent with the results communicated at week 24 and week 52, said Dr Marie Paule Richard, Chief Medical Officer of TiGenix.
“Not only did this long term extension show the safety and tolerability of Cx601 but it indicates that clinical remission was maintained after a single administration of Cx601, as compared with best available standard of care, two years after administration,” Richard said.
Namely, the data from the Cx601 ADMIRE-CD study, a pivotal Phase III trial for complex perianal fistulas in Crohn’s disease patients, showed that the clinical remission rate and difference between groups, as was previously observed at week 24 and week 52, was maintained at week 104. Furthermore, the tolerability of Cx601 was maintained and the safety profiles of Cx601 and placebo (control) were similar for the duration of the trial. Also, no new safety signals were reported during the 2 years extended follow up.
The ADMIRE-CD trial was a randomized, double-blind, placebo-controlled Phase III study designed to confirm the efficacy and safety of a single administration of Cx601 in the treatment of complex perianal fistulas in Crohn’s disease patients. Out of the 212 patients randomized, 37 patients concluded the long term extension from week 52 to week 104, i.e. 23 patients in the Cx601 arm and 14 in the placebo (control) arm. This long term extension was done to confirm the long term safety and tolerability of Cx601.