3 days popular7 days popular1 month popular3 months popular

Cx601 Phase I/IIa Study Published In International Journal Of Colorectal Disease

TiGenix (: TIG) have announced the publication in the of the Phase I/II study of Cx601: Expanded allogeneic adipose-derived stems cells (eASCs) for the treatment of complex perianal in Crohn’s disease: results from a multicenter phase I/II .

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.

“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 Phase III study. is a multicenter, randomized, double-blind, placebo-controlled Phase III trial of Cx601 in approximately 278 Crohn’s disease patients suffering from complex .

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.


“Expanded allogeneic adipose-derived stem cells (eASCs) for the treatment of complex perianal fistula in Crohn’s disease: results from a multicenter phase I/IIa clinical trial” F. de la Portilla, F. Alba, D. García-Olmo, J. M. Herrerías, F. X. González and A. Galindo
International Journal of Colorectal Disease 2012, DOI: 10.1007/s00384-012-1581-9

Source: TiGenix

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 recognised 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.