CX 601 (allogeneic expanded adipose-derived stem cells) filed in EU for complex perianal fistulas in adults with Crohn's disease- TiGenix

TiGenix has announced the submission of a centralized Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for CX 601 (a suspension of allogeneic expanded adipose-derived stem cells) for the treatment of complex perianal fistulas in adult patients with Crohn's disease. This follows the completion of the ADMIRE-CD trial in August, the recently granted license to manufacture Cx601 commercially in Europe and the agreement from the FDA through a Special Protocol Assessment (SPA) on a proposal to conduct a Phase III pivotal trial in the United States.

Cx 601 met the primary endpoint in the Phase III ADMIRE-CD trial in Crohn's disease patients with complex perianal fistulas. A single injection of Cx 601 (stem cell implementation) was statistically superior to placebo in achieving combined remission at week 24, in patients with inadequate response to previous therapies, including anti-TNFs. The study results confirm the favourable safety and tolerability profile of Cx601.