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2015-09-23

TiGenix: AlloCSC-01 Phase I data Presented at the Congress of the European Society of Cardiology

PRESS RELEASE

AlloCSC-01
Phase I Data

Presented at the Congress of the European Society of Cardiology

* CAREMI d ose-escalation open-label phase data presented at the Congress of
the European Society of Cardiology (ESC) confirm the good safety profile of
AlloCSC-01 in patients suffering from Acute Myocardial Infarction (AMI)
* AMI patients treated in the dose-escalation open-label phase showed a
reduction in infarct size and improvement of left ventricular ejection
fraction (LVEF) on Magnetic Resonance Imaging (MRI) after the
administration of AlloCSC-01 over a six-month period

Leuv
en (BELGIUM) - 23 September 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 the CAREMI dose-escalation open-label phase data
were presented at the
Congress of the European Society of Cardiology.

CAREMI is a two phase study: an open-label dose-escalation phase and a
randomised, double-blind, placebo-controlled phase, aiming at evaluating the
safety and efficacy of intracoronary infusion of AlloCSC-01, a suspension of
allogeneic human cardiac stem cells (CSC). In the dose-escalation open-label
phase, 6 patients were treated with AlloCSC-01 and 5 of them were followed up
for 6 months. Patients received a single injection of 11 million (M), 22M or
35M cells of AlloCSC-01 (n=2 each) by intracoronary infusion 5 to 7 days
after Percutaneous Coronary Intervention (PCI). Data presented show that
AlloCSC-01 has a good safety profile as no adverse events or Major Adverse
Cardiac Events (MACE) were observed during the 6 month follow-up period. Of
note, preliminary efficacy data showed a reduction in the infarct size, and a
LVEF improvement on MRI, over the 6-month follow-up period (n=5; p<0.05 for
both parameters).

AlloCSC-01 may become a new approach to prevent cardiac remodelling and the
onset of Cardiac Heart Failure (CHF) after AMI. In the United States and
Europe, approximately 1.5 million AMIs are treated annually. Current AMI
management therapeutic options including Percutaneous Transluminal Coronary
Angioplasty (PTCA), combined with stent implantation, are in most cases
successful in re-establishing the perfusion of the ischemic myocardium and
have helped to reduce the immediate mortality after infarct. However, these
treatments are not able to recover the injured tissue. In fact all currently
approved therapeutic approaches are palliative and designed to preserve the
function of the surviving myocardium.

"We are encouraged with the successful completion of the dose escalation phase
of the CAREMI trial and with the over 70% recruitment rate of the ongoing
randomised, double-blind, placebo-controlled phase", said Marie Paule
Richard, Chief Medical Officer at TiGenix. "CAREMI is expected to complete
recruitment in 4Q 2015 and deliver 6-month interim exploratory efficacy data
during 2H 2016. Final results will be released in the 1H 2017. There is a
huge need for effective treatments that prevent the severe consequences that
follow a myocardial infarction and AlloCSC-01 may represent an innovative
approach for treating those patients".

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 AlloCSC-01

AlloCSC-01 is a cellular product consists of adult allogeneic cardiac stem
cells isolated from the right atrial appendages of donors, and expanded in
vitro. Pre-clinical data has shown evidence of the strong cardio-protective
and immune-regulatory activity of AlloCSC-01. In vivo studies suggest that
AlloCSC-01 has cardio-reparative potential by activating endogenous
regenerative pathways and by promoting the formation of new cardiac tissue.
In addition, AlloCSC-01 has displayed a strong tropism for the heart enabling
a high retention of cells in the myocardium after intracoronary
administration. AlloCSC-01 is currently in clinical development in a Phase
I/II clinical trial (CAREMI). The CAREMI trial comprises two consecutive
phases: an open-label dose-escalation phase (n=6) and a 2:1 randomised,
double-blind, placebo-controlled phase (n=49). The objective of this clinical
trial is to evaluate the safety and the efficacy of the cardiac stem cells
product AlloCSC-01 in the acute phase of ischemic heart disease. The primary
endpoint of the CAREMI Phase I is all-cause mortality within 30 days and all
adverse events of any cause from the patient's inclusion until 7 days after
treatment administration. Secondary endpoints for this dose escalation phase
include efficacy MRI parameters (evolution of infarct size and evolution of
biomechanical parameters), clinical parameters (including the 6 minute
walking test and the New York Heart Association scale) and safety (all AEs
within 30 days, then monthly up to 6 months, then quarterly post-AlloCSC-01,
all-cause mortality and death from cardiovascular cause at 12 months, and
MACE measured at 6 and 12 months). Eight centers are participating in Spain
and Belgium and patient recruitment is in an advanced stage. Final results
will be released in the first half of 2017 with a six-month interim
exploratory analysis expected to provide data in the second half of 2016.

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 are beyond the Company's 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 the Company's 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.

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This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: TiGenix via Globenewswire

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