TiGenix’s Phase III trial design for Cx601 endorsed by President-Elect of ECCO

TiGenix NV, an advanced biopharmaceutical company focused on developing and commercialising novel therapeutics from its proprietary platform of allogeneic expanded adipose-derived stem cells in inflammatory and autoimmune diseases, announced today that Dr Julian Panés, a leading clinical specialist in inflammatory bowel disease, endorsed the design of the Company’s Phase III trial of Cx601 for the treatment of complex perianal fistulas in patients with Crohn’s disease during his presentation last week at the 10^th Annual Congress of the European Crohn’s and Colitis Organisation (ECCO) held in Barcelona, Spain.

Cx601 is a suspension of allogeneic expanded adipose-derived stem cells (eASCs) delivered locally through intra-lesional injection that is being developed for the treatment of perianal fistulas in Crohn’s disease patients. Such fistulas cause severe complications and are difficult to manage, and have a significant negative impact on patient quality of life and psychological well-being. There is currently no effective treatment. In 2009, the European Commission granted Cx601 orphan designation for the treatment of anal fistulas, recognising the debilitating nature of the disease and the lack of treatment options.

TiGenix is conducting a randomised, double-blind, placebo-controlled Phase III trial in Europe and Israel designed to comply with the requirements laid down by the European Medicines Agency (EMA). This pivotal study, codenamed ‘ADMIRE’, has recruited 289 patients across 52 centres in 7 European countries and Israel. The results of the study will be available in the third quarter of 2015 and, if positive, will allow TiGenix to submit a request for marketing authorisation to the EMA early in 2016.

Dr. Julian Panés, who is Head of the Gastroenterology Department, Head of the Inflammatory Bowel Diseases Unit, and Associate Professor of Medicine at the Hospital Clínic of Barcelona, President-elect of ECCO and Chairman of the TiGenix ADMIRE Scientific Advisory Board, made his comments during a presentation last week at the Annual Congress of ECCO in a session entitled, ‘Mesenchymal Stem Cells in Inflammatory Bowel Disease: promises and pitfalls’.

“I strongly believe that there are not in general adequately designed and controlled studies of the role of stem cells in the treatment of perianal fistulas in Crohn’s disease patients,” Dr. Panes said. “In the pivotal Phase III ADMIRE trial of TiGenix, we finally have the robust, controlled study that we have been waiting for.”

“The positive evaluation of our Phase III study by Dr. Panés is strong recognition of the quality of our study design”, commented Dr. Marie-Paule Richard, Chief Medical Officer at TiGenix. “We remain committed to bringing this new treatment to the thousands of patients who suffer from this debilitating condition”.