9 October 2012

TiGenix announces publication of Cx601 Phase I/IIa study in International Journal of Colorectal Disease

Leuven (BELGIUM) – October 9, 2012 – TiGenix (Euronext Brussels: TIG) announced today the publication in the International Journal of Colorectal Disease of the Phase I/II study of Cx601: Expanded allogeneic adipose-derived stems cells (eASCs) for the  treatment of complex perianal fistula in Crohn’s disease: results from a multicenter phase  I/II clinical trial.

The authors of the study state that the full analysis of efficacy data at week 24 showed  69.2% of the patients with a reduction in the number of draining fistulas, while 56.3% of the  patients achieved complete closure of the treated fistula, and 30% of the cases presented  complete closure of all existing fistula tracts. The study, which is published online ahead of  print, can be accessed here: http://www.springerlink.com/content/j6k615530320kr02/

“We are delighted with the publication in a reputed clinical journal of this study that confirms  the significant benefit of our lead development product Cx601 in a very challenging  indication for which current treatments are suboptimal,” said Eduardo Bravo, CEO of  TiGenix. “The publication of these results in a peer-reviewed journal is a validation of the  thoroughness of our development program and demonstrates the increasing prominence of  cell therapy as an accepted clinical strategy that has the potential to considerably improve  on existing treatments paradigms.”

Cx601 is an adipose-derived allogeneic stem cell therapy that is delivered locally in the  fistula through intra-lesional injection. Cx601 is currently being investigated in the ADMIRECD Phase III study. ADMIRE-CD is a multicenter, randomized, double-blind, placebocontrolled Phase III trial of Cx601 in approximately 278 Crohn’s disease patients suffering  from complex perianal fistulas. The main objectives of the study are to demonstrate safety  and superior efficacy over placebo in perianal fistulas in Crohn’s disease patients after  failure with their previous treatment, in most cases biologicals, and to confirm the strong  safety and efficacy results from the Phase II trial completed in 2011. The results from  ADMIRE CD are expected in H2, 2014. Information on the ADMIRE-CD trial can be found  at www.clinicaltrials.gov.

About TiGenix

TiGenix NV (NYSE Euronext Brussels: TIG) is a leading European cell therapy company with a marketed cell therapy product for cartilage repair, ChondroCelect®, and a strong pipeline with clinical stage allogeneic adult stem cell programs for the treatment of autoimmune and inflammatory diseases. TiGenix is based out of Leuven (Belgium) and has operations in Madrid (Spain), and Sittard-Geleen (the Netherlands). For more information please visit www.tigenix.com.

Forward-looking information
This document may contain forward-looking statements and estimates with respect to the anticipated future performance of TiGenix and the market in which it operates. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar expressions. They include all matters that are not historical facts. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond TiGenix’ control. Therefore, actual results, the financial condition, performance or achievements of TiGenix, or industry results, may turn out to be materially different from any future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward looking statements, forecasts and estimates only speak as of the date of the publication of this document. TiGenix disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in TiGenix’ expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement, forecast or estimate is based, except to the extent required by Belgian law.

For more information:


Eduardo Bravo
Chief Executive


Claudia D’Augusta
Officer Chief Financial Officer


Hans Herklots
Director Investor & Media Relations
+32 16 39 60 97