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.
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.
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