2012-10-09 07:05:16 -
Regulated information
October 9, 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:
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 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. Information on the
ADMIRE-CD trial can be found at www.clinicaltrials.gov.
For more information:
Eduardo Bravo
Chief Executive Officer
eduardo.bravo@tigenix.com
Claudia D'Augusta
Chief Financial Officer
claudia.daugusta@tigenix.com
Hans Herklots
hans.herklots@tigenix.com
+32 16 39 60 97
About TiGenix
TiGenix NV (Euronext Brussels: TIG) is a leading European cell therapy company
with a marketed 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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