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2015-08-23

TiGenix: TiGenix :TiGenix announces Cx601 meets primary endpoint in pivotal Phase III trial

Regulated information

PRESS RELEASE

TiGenix announces
Cx601 meets

primary endpoint in pivotal Phase III trial

* A single injection of Cx601 was statistically superior to placebo in
achieving combined remission at week 24 of complex perianal fistulas in
Crohn's disease patients with inadequate response to previous therapies,
including anti-TNFs
* More than 50% of patients treated with Cx601 achieved combined remission at
week 24
* A higher number of Cx601-treated patients had their fistulas closed by week
6
* The results confirm the favourable safety and tolerability profile of Cx601

* These positive data allow for European filing in the first quarter of 2016
and moving forward in the US with the SPA [1]-approved pivotal study

Leuven (BELGIUM) - 23 August 2015 - TiGenix NV (Euronext Brussels: TIG), an
advanced biopharmaceutical company focused on developing and commercialising
novel therapeutics from its proprietary platforms of allogeneic expanded stem
cells, announced today that its lead compound Cx601 met the primary endpoint
in the Phase III ADMIRE-CD trial in Crohn's disease patients with complex
perianal fistulas. Cx601 is a suspension of allogeneic expanded
adipose-derived stem cells (eASC) injected intra-lesionally. A single
injection of Cx601 was statistically superior to placebo in achieving
combined remission at week 24, in patients with inadequate response to
previous therapies, including anti-TNFs. The study results confirm the
favourable safety and tolerability profile of Cx601.

ADMIRE-CD is a randomised, double-blind, placebo-controlled Phase III study
designed to confirm the efficacy and safety of a single injection of Cx601 in
the treatment of complex perianal fistulas in Crohn's disease patients. In
total, 289 patients were recruited across 50 active sites in 7 European
countries and Israel. Patients included had an inadequate response to
previous therapies, including anti-TNFs. Continuation of medical standard of
care was allowed during the duration of the trial in both groups. The study
primary endpoint was combined remission at week 24, defined as closure of all
treated external openings draining at baseline despite gentle finger
compression, and absence of collections>2cm confirmed by MRI[2].

In the ITT[3]population (n=212), Cx601 achieved statistically significant
superiority (p<0.025) with 49.5% combined remission at week 24 compared to
34.3% in the placebo arm. In the mITT[4]population (n=204), the combined
remission rates at week 24 were 51.5% and 35.6% for Cx601 and placebo,
respectively (p<0.025). These results translate into an observed relative
risk of 1.44, meaning that patients receiving Cx601 had 44% more chances to
achieve combined remission than placebo patients. Efficacy results were
robust and consistent across all statistical populations.

Treatment-emergent adverse events (non-serious and serious) and
discontinuations due to adverse events were comparable between Cx601 and
placebo arms.

"We are extremely excited about the results of Cx601 in this severely
debilitating and difficult to treat condition. Achieving more than 50%
combined remission in patients who have not responded adequately to previous
treatments, including anti-TNFs, is a remarkable accomplishment", said Dr
Marie Paule Richard, Chief Medical Officer of TiGenix. "We are committed to
submit these data to the EMA and to bring this innovative new treatment to
patients whose life is impacted by the challenges of this serious condition".

Full efficacy and safety results will be presented at the 11thCongress of ECCO
(European Crohn's and Colitis Organisation).

"The results of this large robust controlled study are clinically relevant and
open a completely new avenue for the treatment of perianal fistulising
Crohn's disease, one of the most severe manifestation of this process. The
therapy affords a 44% increased chance for patients of closing their fistula
with a single injection, which is a major breakthrough", said Dr Julián
Panés, Head of the Gastroenterology Department, Head of the Inflammatory
Bowel Diseases Unit, and Associate Professor of Medicine at the Hospital
Clínic of Barcelona, President-Elect of ECCO, and Chairman of TiGenix
ADMIRE-CD Scientific Advisory Board.

"This is a landmark achievement for TiGenix", said Eduardo Bravo, CEO of
TiGenix. "These positive results, together with the recent endorsement by the
FDA of our Phase III trial design for the US, let us move full steam ahead
making Cx601 available to the more than 100.000 patients who every year
suffer from this serious condition".

Webcast and conference call

On Monday 24 August, at 15:00h CET/9:00h EDT, TiGenix will conduct a
conference call and webcast. The following speakers will present the Top-Line
results of the trial, explain the next steps for Cx601 and the Company, and
will take questions:

* Mr Eduardo Bravo, Chief Executive Officer of TiGenix
* Dr Marie Paule Richard, Chief Medical Officer of TiGenix
* Dr Julián Panés, Head Gastroenterology Department, Head IBD Unit, and
Associate Professor of Medicine at Hospital Clínic of Barcelona,
President-Elect of ECCO, and Chairman of TiGenix ADMIRE-CD Scientific
Advisory Board

Please dial one of the following numbers to participate:
Belgium: +32 (0) 2404 0662

Canada: +1 514 841 2154

France: +33 (0) 1 76 77 22 26

Netherlands: +31 (0) 20 716 8257

Spain: +34 91 453 3445

Sweden: +46 (0) 8 5065 3936

United Kingdom: +44 (0) 20 3427 1900

United States of America: +1 646 254 3365
Confirmation code: 8585083

The webcast can be followed live online via the link:

http://edge.media-server.com/m/p/kvidxhyn

The press release and the webcast slide presentation will be made available in
the Newsroom section of the TiGenix website. A replay of the webcast will be
available on the website shortly after the live webcast has finished.

For more information

Claudia D'Augusta

Chief Financial Officer

T: +34 91 804 92 64

claudia.daugusta@tigenix.com

Ana Pombo

Strategic Planning and IR Manager

T: + 34 91 804 92 64

ana.pombo@tigenix.com
About Cx601

Cx601 is a suspension of allogeneic expanded adipose-derived stem cells (eASC)
intra-
lesionally injected.
Cx601 is being developed for the treatment of
complex
perianal fistulas in Crohn's disease patients.
Crohn's disease is a chronic inflammatory disease of the intestine and
patients can suffer from complex perianal fistulas for which there is
currently no effective treatment. In 2009, the European Commission granted
Cx601 orphan designation for the treatment of anal fistulas, recognising the
debilitating nature of the disease and the lack of treatment options
.
Based on positive Phase II
results,
TiGenix sought scientific advice from the European Medicines Agency (EMA) on
the future development path of Cx601. TiGenix then initiated a randomised,
double-blind, placebo-controlled Phase III trial in Europe and Israel
designed to comply with the requirements laid down by the EMA. 'Madrid
Network', an organisation within the Autonomous Region of Madrid which helps
companies to grow through high-technology innovation, issued a soft loan to
help finance this Phase III study. The programme is funded by The Secretary
of State for Research, Development and Innovation (Ministry of Economy and
Competitiveness) within the framework of the INNTEGRA plan. The study primary
endpoint is combined remission, defined as clinical assessment at week 24 of
closure of all treated external openings draining at baseline despite gentle
finger compression, and absence of collections>2cm confirmed by MRI. The
trial has a first complete analysis of results at 24 weeks, with a follow-up
analysis to be performed at 52 weeks post-treatment. Recruitment of the whole
sample of patients was completed in the fourth quarter of 2014. Based on the
positive Phase III results, TiGenix will submit a Marketing Authorisation
Application to EMA early 2016. TiGenix is preparing to develop Cx601 for the
US market after having
obtained FDA's endorsement
of its pivotal Phase III trial
through SPA on the 7thof August 2015.

About TiGenix

TiGenix NV (Euronext Brussels: TIG) is an advanced biopharmaceutical company
focused on developing and commercialising novel therapeutics from its
proprietary
platforms
of allogeneic, or donor-derived, expanded stem cells. Two products from the
adipose-derived technology platform are currently in clinical development.
Cx601 is in Phase III for the treatment of complex perianal fistulas in
Crohn's disease patients. Cx611 has completed a Phase I/II trial in
rheumatoid arthritis, as well as
a Phase I sepsis challenge trial. Effective as of July 31, 2015, TiGenix
acquired Coretherapix, whose lead cellular product (AlloCSC-01) is currently
in a Phase II clinical trial in acute myocardial infarction (AMI).
Coretherapix is planning to initiate the clinical evaluation of AlloCSC-01 in
the chronic setting as well and is also involved in the pre-clinical
development of a pharmaceutical formulation of growth factors to treat AMI.
Finally,
TiGenix also developed ChondroCelect, an autologous cell therapy product for
cartilage repair of the knee, which was the first Advanced Therapy Medicinal
Product (ATMP) to be approved by the European Medicines Agency (EMA). From
June 2014, the marketing and distribution rights of ChondroCelect were
exclusively licensed to Sobi for
the European Union (except for Finland, where it is distributed by the Finnish
Red Cross Blood Service), Norway, Russia, Switzerland and Turkey, and the
countries of the Middle East and North Africa.
TiGenix is headquartered in Leuven (Belgium) and has operations in Madrid
(Spain).

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 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 ...

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