TiGenix: AlloCSC-01 Phase I data Presented at the Congress of the European Society of Cardiology
(Thomson Reuters ONE) -
PRESS RELEASE
AlloCSC-01 Phase I Data
Presented at the Congress of the European Society of Cardiology
* CAREMI dose-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
Leuven (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(at)tigenix.com
Ana Pombo
Strategic Planning and IR Manager
T: + 34 91 804 92 64
ana.pombo(at)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.
This announcement is distributed by GlobeNewswire on behalf of
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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
[HUG#1953750]
Unternehmensinformation / Kurzprofil:
Datum: 23.09.2015 - 07:00 Uhr
Sprache: Deutsch
News-ID 421972
Anzahl Zeichen: 10808
contact information:
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Business News
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