Leuven (BELGIUM) - 9th March, 2017, 7:00 am CET - TiGenix NV (Euronext Brussels and Nasdaq: TIG), an advanced biopharmaceutical company focused on developing and commercializing novel therapeutics from its proprietary platforms of allogeneic stem cells, today announced week 104 data from the Cx601 ADMIRE-CD study, a pivotal Phase III trial for complex perianal fistulas in Crohn’s disease patients.
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.
The topline data of this second year of follow up indicate the following:
• The Clinical remission rate and difference between groups, as was previously observed at week 24 and week 52, was maintained at week 104
• The tolerability of Cx601 was maintained
• The safety profiles of Cx601 and placebo (control) were similar for the duration of the trial
• No new safety signals were reported during the 2 years extended follow up
“This is the final set of data from this landmark ADMIRE-CD study. The week 104 data on the patients who stayed in the trial continue to prove the value of Cx601 for this very difficult to treat patient population, and 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,” concluded Dr Richard.
