TiGenix announces acceptance of Cx601 abstract for oral presentation at 12th Congress of ECCO
(Thomson Reuters ONE) -
PRESS RELEASE
TiGenix announces acceptance of Cx601
abstract for oral presentation at
12(th) Congress of ECCO
Leuven (BELGIUM) - 6(th) February, 2017, 07:30h CET - TiGenix NV (Euronext
Brussels and Nasdaq: TIG), an advanced biopharmaceutical company focused on
developing and commercializing novel therapeutics from its proprietary platforms
of allogeneic expanded stem cells, today announced that the abstract related to
the positive results of the ADMIRE-CD pivotal Phase III trial of Cx601 for
complex perianal fistulas in Crohn's disease patients after 52 weeks has been
accepted for oral presentation at the upcoming 12th Annual Congress of the
European Crohn's and Colitis Organization (ECCO).
In this oral presentation, Dr. Julián Panés, Global Study Coordinator, will
present new data from the Phase III ADMIRE-CD clinical trial conducted in
Crohn's disease patients with complex perianal fistulas who had an inadequate
response to at least one conventional or biologic therapy. This data
demonstrated that the remission produced in these hard-to-treat fistulas by
Cx601, a suspension of allogeneic adipose-derived stem cells (eASC), was
maintained long-term (over 52 weeks).
"The efficacy of Cx601 in treatment-refractory complex perianal fistulas of CD
patients was sustained for up to 1 year after a single administration," said Dr.
Marie Paule Richard, Chief Medical Officer at TiGenix. "The results also support
the favorable tolerability of Cx601 over the long-term".
Details of the abstract and timing of the oral presentation are provided below.
Session name: Scientific Session 4: Clinical trials versus real
life
Session date: Friday, February 17, 2017
Session time: 08:30-10:30h (CET)
Presentation time: 09:10-09:20h (CET)
Session hall: Plenary Hall
Address: CCIB Barcelona, Plaça de Willy Brandt
11-14, 08019 Barcelona, Spain
Abstract A-1325: Long-term efficacy and safety of Cx601, allogeneic expanded
adipose-derived mesenchymal stem cells, for complex perianal fistulas in Crohn's
disease: 52-week results of a phase III randomized controlled trial
Lead author: Prof Dr. Julián Panés, Department of Gastroenterology, Hospital
Clínic, Barcelona, Spain
TiGenix has an exclusive licensing and commercialization agreement for Cx601,
ex-US, with Takeda and expects a decision from the EMA regarding its marketing
authorization by year-end 2017. Takeda could launch Cx601 thereafter.
For more information
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 commercializing novel therapeutics from its
proprietary platforms of allogeneic, or donor-derived, expanded stem cells. Our
lead product candidate from the adipose-derived stem cell technology platform is
Cx601, which is in registration with the European Medicines Agency for the
treatment of complex perianal fistulas in Crohn's disease patients. Our adipose-
derived stem cell product candidate 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 candidate,
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. On July 4, 2016, TiGenix entered into a
licensing agreement with Takeda, a large pharmaceutical company active in
gastroenterology, under which Takeda acquired the exclusive right to
commercialize Cx601 for complex perianal fistulas outside the United States.
TiGenix is headquartered in Leuven (Belgium) and has operations in Madrid
(Spain).
About Cx601
Cx601 is a suspension of allogeneic expanded adipose-derived stem cells (eASC)
locally injected. Cx601 is an investigational agent being developed for the
treatment of complex perianal fistulas in Crohn's disease patients with
inadequate response to at least one conventional or biologic therapy including
antibiotics, immunosuppressants, or anti-TNF agents. 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, recognizing the debilitating nature of the disease
and the lack of treatment options. Cx601 has met the primary end-point in the
Phase III ADMIRE-CD study in Crohn's disease patients with complex perianal
fistula, a randomized, double-blind, placebo-controlled trial run in Europe and
Israel and designed to comply with the requirements laid down by the EMA.
'Madrid Network' issued a soft loan to help finance this Phase III study, which
was 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 ITT population (n=212), Cx601 achieved statistically
significant superiority (p=0.024) on the primary endpoint with 50% combined
remission at week 24 compared to 34% in the placebo arm. 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 24-weeks results have
been published by The Lancet, one of the most highly regarded and well known
medical journals in the world. The Phase III study has completed a follow-up
analysis at 52 weeks confirming its sustained efficacy and safety profile. Top
line follow-up data showed that in the ITT population Cx601 achieved statistical
superiority (p=0.012) with 54% combined remission at week 52 compared to 37% in
the placebo arm. The 52-week data also showed a higher rate of sustained closure
in those patients treated with Cx601 and in combined remission at week 24
(75.0%) compared to patients in the placebo group (55.9%). Based on the positive
24-weeks Phase III study results, TiGenix has submitted a Marketing
Authorization Application to the EMA in early 2016. TiGenix is preparing to
develop Cx601 in the U.S. after having reached an agreement with the FDA through
a special protocol assessment procedure (SPA) in 2015. On July 4, 2016 TiGenix
entered into a licensing agreement with Takeda, a pharmaceutical company leader
in gastroenterology, whereby Takeda acquired an exclusive right to commercialize
Cx601 for complex perianal fistulas in Crohn's patients outside of the U.S.
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.
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq 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
Unternehmensinformation / Kurzprofil:
Datum: 06.02.2017 - 07:30 Uhr
Sprache: Deutsch
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