TiGenix (Euronext Brussels: TIG) have announced 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.
“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 ADMIRE-CD Phase III study. ADMIRE-CD is a multicenter, randomized, double-blind, placebo-controlled 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.
“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
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