Leuven (BELGIUM) - 6th February, 2017, 07:30h 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 expanded stem cells, today announced that the abstract related to the positive results of the ADMIRE-CD pivotal Phase III trial of Cx601 for complex perianal fistulas in Crohn’s disease patients after 52 weeks has been accepted for oral presentation at the upcoming 12th Annual Congress of the European Crohn’s and Colitis Organization (ECCO). In this oral presentation, Dr. Julián Panés, Global Study Coordinator, will present new data from the Phase III ADMIRE-CD clinical trial conducted in Crohn’s disease patients with complex perianal fistulas who had an inadequate response to at least one conventional or biologic therapy. This data demonstrated that the remission produced in these hard-to-treat fistulas by Cx601, a suspension of allogeneic adipose-derived stem cells (eASC), was maintained long-term (over 52 weeks).
“The efficacy of Cx601 in treatment-refractory complex perianal fistulas of CD patients was sustained for up to 1 year after a single administration,” said Dr. Marie Paule Richard, Chief Medical Officer at TiGenix. “The results also support the favorable tolerability of Cx601 over the long-term”.
Details of the abstract and timing of the oral presentation are provided below.
Session name: Scientific Session 4: Clinical trials versus real life
Session date: Friday, February 17, 2017
Session time: 08:30-10:30h (CET)
Presentation time: 09:10-09:20h (CET)
Session hall: Plenary Hall
Address: CCIB Barcelona, Plaça de Willy Brandt 11-14, 08019 Barcelona, Spain
Abstract A-1325: Long-term efficacy and safety of Cx601, allogeneic expanded adipose-derived mesenchymal stem cells, for complex perianal fistulas in Crohn’s disease: 52-week results of a phase III randomized controlled trial Lead author: Prof Dr. Julián Panés, Department of Gastroenterology, Hospital Clínic, Barcelona, Spain
TiGenix has an exclusive licensing and commercialization agreement for Cx601, ex-US, with Takeda and expects a decision from the EMA regarding its marketing authorization by year-end 2017. Takeda could launch Cx601 thereafter.
