TiGenix Cx601 positive Phase III results to be presented at Digestive Disease Week in the USA
(Thomson Reuters ONE) -
PRESS RELEASE
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 disease.
"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:
TiGenix
Claudia D'Augusta
Chief Financial Officer
T: +34 91 804 92 64
claudia.daugusta(at)tigenix.com
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 www.tigenix.com.
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.
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[1] ITT: Intention to Treat i.e. all patients randomized.
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(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: TiGenix via GlobeNewswire
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