Belgium-based biopharmaceutical company TiGenix has reported positive topline week 104 results from the Phase III clinical trial (ADMIRE-CD) of Cx601 for the treatment of complex perianal fistulas in patients with Crohn's disease.
Cx601 is an investigational suspension of allogeneic, expanded adipose-derived stem cells (eASC) developed for Crohn's disease patients with inadequate response to at least one conventional or biologic therapy, including antibiotics, immunosuppressants or anti-TNF agents.
The randomised, double-blind, placebo-controlled Phase III trial evaluated the efficacy and safety of a single administration of Cx601 in 212 patients.
TiGenix chief medical officer Marie Paule Richard said: "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.
"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, compared with best available standard of care two years after administration."
During the extension from week 52 to week 104, which was performed to confirm the long-term safety and tolerability, it was found that 23 patients in the Cx601 arm concluded the extension when compared to 14 in the placebo arm.
The tolerability and safety profiles were also found to be consistent with the results observed at week 24 and week 52.
Cx601 secured orphan designation from the European Commision in 2009 for the treatment of anal fistulas.