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TiGenix: TiGenix Cx601 positive Phase III results to be presented at Digestive Disease Week in the USA


TiGenix Cx601 positive Phase III results to be presented at Digestive Disease
Week in the USA

Leuven (BELGIUM) - May 18, 2016, 7:00am CET - TiGenix NV (Euronext Brussels:
TIG), an advanced biopharmaceutical company focused on developing and
commercializing novel therapeutics from its proprietary platforms of
allogeneic expanded stem cells, is proud to present the week 24 positive
results from its Phase III ADMIRE-CD pivotal study of Cx601 at the 2016
Digestive Disease Week (DDW) in San Diego, California (USA).

The ADMIRE-CD Phase III 24-week positive results will be presented by
Professor Julian Panés, Head of the Gastroenterology Department, at the
Hospital Clinic of Barcelona and Chairman of the TiGenix ADMIRE-CD Scientific
Advisory Board in Europe, at the DDW session dedicated to Controlled Clinical
Trials in Inflammatory Bowel Diseases on May 24, 2016 at 8:00am PDT. The DDW
is the largest congress with international attendees organized in the US for
this therapeutic field of physicians, researchers and academics in the fields
of gastroenterology, hepatology, endoscopy and gastrointestinal surgery.

In this double-blind, placebo controlled, randomized Phase III study, Cx601
met the primary endpoint of combined remission of complex perianal fistulas
at week 24. As recently reported, Cx601 continued to show a sustained effect
at week 52, while confirming the favorable safety and tolerability profile of
the treatment. Combined remission is defined as the clinical assessment of
the closure of all treated external openings draining at baseline combined
with the absence of collection>2 of the treated perianal fistulas confirmed
by central blinded MRI, and it is a more stringent definition of remission
than the one commonly used in clinical trials on perianal fistulizing

"The sustained effect of Cx601 after single injection is remarkable,
particularly considering that a majority of patients treated were refractory
to available therapies," said Dr. Julián Panés. "Cx601 has shown to provide a
durable, effective and safe therapeutic alternative to address this serious
clinical condition," he continued.

"Having been selected to present at DDW for an oral presentation, speaks of
the quality of the ADMIRE-CD study," remarked Dr. Marie Paule Richard, Chief
Medical Officer at TiGenix. "We are honored to present our Phase III results
to the US medical community at such a prestigious congress, and are confident
this will raise the awareness of Cx601, especially as we prepare to initiate
our pivotal Phase III trial for registration in the United States," she said.

"Following the FDAs agreement on the new Phase III design and planned
analysis, Cx601 benefits from a clearly defined development and regulatory
path for approval in the U.S.," commented Dr. William J. Sandborn, Professor
of Medicine and Adjunct Professor of Surgery, Chief of Gastroenterology, and
Director of the UCSD Inflammatory Bowel Disease Center, University of
California San Diego and UC San Diego Health System, San Diego. Dr. Sandborn;
who is also the Chairman of TiGenix's US Scientific Advisory Board, affirmed,
"Cx601 has proven to be a novel approach to treat complex perianal fistulas,
for which there is still no cure. In the US alone, 30,000 patients are
waiting for an effective treatment for this debilitating disease."

This is the first ever positive Phase III trial with an allogeneic stem cell
product, which confirms TiGenix's leadership position in the field of cell
therapy. TiGenix submitted a Marketing Authorization Application for Cx601 in
first quarter of 2016 to the European Medicines Agency, and expects to begin
marketing in European markets in the second half of 2017.

For more information, please contact:

Claudia D'Augusta
Chief Financial Officer
T: +34 91 804 92 64

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 stem cell 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 sepsis challenge trial and a Phase I/II trial in rheumatoid
arthritis. Effective 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). In addition, the second product candidate
from the cardiac stem cell-based platform acquired from Coretherapix,
AlloCSC-02, is being developed in a chronic indication. 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

About Cx601

Cx601 is a suspension of allogeneic expanded adipose-derived stem cells (eASC)
injected intra-lesionally. 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 (the
ADMIRE-CD trial). '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's primary endpoint was 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. In the ADMIRE-CD trial, the results of
which were reported in August 2015, Cx601 achieved statistically significant
superiority (p<0.025) on the primary endpoint with 49.5% combined remission
at week 24 compared to 34.3% in the placebo arm in the ITT[1]population.
These results translate into a relative risk of 1.44, meaning that patients
receiving Cx601 had a 44% greater probability of achieving 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. The ADMIRE-CD trial has completed a follow-up
analysis at 52 weeks post-treatment. Based on the positive 24 week Phase III
results, TiGenix has submitted a Marketing Authorisation Application to the
EMA in early 2016. TiGenix is preparing to develop Cx601 for the US market
after having reached an agreement with the FDA through a special protocol
assessment, or SPA, procedure on its proposed protocol on August 7, 2015.

Forward-looking information

This press release 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 press release. 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.
---------------------------------------[1]ITT: Intention to Treat i.e. all patients randomized.


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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