TiGenix NV will present the week 24 positive results from its Phase III ADMIRE-CD pivotal study of Cx601 at the 2016 Digestive Disease Week in San Diego on May 24.
Here are five highlights:
1. Julian Panés, head of the gastroenterology department at the Hospital Clinic of Barcelona in Spain and chairman of the TiGenix ADMIRE-CD Scientific Advisory Board in Europe, will present the results.
2. In the double-blind, placebo controlled, randomized study, Cx601 met the primary endpoint of combined remission of complex perianal fistulas at week 24.
3. This is the first ever positive Phase III trial with an allogeneic stem cell product.
4. TiGenix submitted a Marketing Authorization Application for Cx601 in the first quarter of 2016 to the European Medicines Agency and expects to begin marketing the product in European markets in the second half of 2017.
5. Headquartered in Belgium, TiGenix is an advanced biopharmaceutical company focused on developing and commercializing novel therapeutics from its proprietary platforms of allogeneic expanded stem cells.