TiGenix: SEPCELL project in severe sepsis receives ?5.4M grant from the EU's Horizon 2020
(Thomson Reuters ONE) -
* TiGenix is leading the SEPCELL project which aims to accelerate the clinical
development of Cx611 in severe sepsis
* The ?5.4M grant will fund the SEPCELL Phase Ib/IIa trial of Cx611 in
patients with severe sepsis secondary to severe community-acquired pneumonia
(sCAP)
Leuven (BELGIUM) - 2 November 2015 - TiGenix NV (Euronext Brussels: TIG), an
advanced biopharmaceutical company focused on developing and commercialising
novel therapeutics from its proprietary platforms, today announced that the
SEPCELL project has been awarded a ?5.4M grant from the European Commission
under Horizon 2020, the European Union's framework programme for research and
innovation, to conduct a clinical Phase Ib/IIa trial of Cx611 in patients with
severe sepsis secondary to severe community-acquired pneumonia (sCAP).
The SEPCELL project is a Phase Ib/IIa randomised, double-blind, parallel group,
placebo-controlled, multicentre study designed to evaluate the safety and
efficacy of Cx611 for the treatment of adult patients with severe sepsis
secondary to sCAP and admitted to the intensive care unit. Cx611 is an
intravenously-administered suspension of allogeneic expanded adipose-derived
stem cells (eASCs). The trial is expected to enroll a total of 180 patients
across Europe.
Cx611 is an innovative approach to the treatment of severe sepsis, using the
immunomodulatory properties of eASCs to target different pathways. Current
standard of care is palliative and supportive, primarily aimed at controlling
symptoms and treating the underlying infection through the use of anti-
inflammatory drugs and antibiotics.
"The award of ?5.4M grant to SEPCELL by the European Commission underscores the
relevance and innovative character of our project and will allow TiGenix to
significantly advance the development of a new therapy for severe sepsis
secondary to severe CAP, a life-threatening condition with high mortality rates
of around 28-50%" said Dr Marie Paule Richard, Chief Medical Officer of TiGenix.
The unique properties of Cx611 have made SEPCELL one of the few clinical
projects to obtain the support of the European Commission under the Horizon
2020 programme. In addition to TiGenix, the SEPCELL consortium comprises the
Centre Hospitalier Universitaire of Limoges, the Cliniques Universitaires Saint-
Luc in Brussels, the Hospital Clínico San Carlos of the Servicio Madrileño de
Salud in Madrid, and the Academic Medical Center of the University of Amsterdam.
TiGenix, as project coordinator, will lead the project, receiving ?1.3M of non-
dilutive funds, and will be responsible for managing the remaining ?4.1M to fund
the activities of the consortium's clinical and research partners.
For more information please contact
TiGenix
Claudia D'Augusta
Chief Financial Officer
T: +34 91 804 92 64
claudia.daugusta(at)tigenix.com
About Severe Sepsis
Sepsis is a systemic inflammatory response to infection, which includes
activation of leukocytes, the release of cytokines and chemokines, the
activation of the coagulation system and activation of endothelial cells. An
international consensus panel proposed the term 'severe sepsis' to describe
instances in which sepsis is complicated by acute organ dysfunctions, while the
term 'septic shock' was defined as sepsis complicated by either hypotension that
is refractory to fluid resuscitation or by hyperlactatemia. Severe sepsis and
septic shock have a significant and increasing impact on public health, and are
one of the leading causes of mortality in intensive care units. The epidemiology
of sepsis, severe sepsis and septic shock shows an incidence of 3 cases per
1,000 population and is increasing due to the ageing of the population, an
increase in drug-resistant bacteria and the weakening of the immune system
caused by several factors.
About Cx611 in Severe Sepsis
Cx611 is an intravenously-administered product of allogeneic expanded adipose-
derived stem cells (eASCs). In May 2015, TiGenix completed a Phase I sepsis
challenge trial demonstrating the favourable safety and tolerability profile of
Cx611. Based on the results of this study, TiGenix has designed a Phase Ib/IIa
trial in severe sepsis secondary to severe community-acquired pneumonia (sCAP)
which is expected to enroll 180 patients across Europe (the SEPCELL project).
SEPCELL has been awarded a ?5.4M grant by the European Union under the Horizon
2020 Research and Innovation Programme under Grant Agreement 681031.
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).
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.
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(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
[HUG#1963065]
Unternehmensinformation / Kurzprofil:
Datum: 02.11.2015 - 07:00 Uhr
Sprache: Deutsch
News-ID 430969
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contact information:
Town:
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