TiGenix Launches Global Phase III Trial for Cx601
(Thomson Reuters ONE) -
PRESS RELEASE
TiGenix Launches Global Phase III Trial for Cx601
Leuven (BELGIUM) - June 13, 2017, 07:00h CEST - TiGenix NV (Euronext Brussels
and NASDAQ: TIG), an advanced biopharmaceutical company focused on exploiting
the anti-inflammatory properties of allogeneic, or donor-derived, stem cells to
develop novel therapies for serious medical conditions, today announces that it
has hosted its first European investigator meeting, which formally launches the
global pivotal phase III clinical trial for Cx601 for the treatment of complex
perianal fistulas in patients with Crohn's disease. Similar investigator
meetings are planned to take place in Europe (EU), Israel, the United States and
Canada from the fourth quarter of 2017. The global trial is designed to support
a future regulatory filing for Cx601 in the U.S.
The first investigator meeting, held on June 8 and June 9 in Rome, Italy,
brought together more than 60 leading gastroenterologists, colorectal surgeons
and study co-ordinators from 30 confirmed clinical trial sites across Belgium,
Czech Republic, Italy, Poland and Spain. Presentations were given by national
and regional study co-ordinators, including the principal EU/Israel
gastroenterologist study co-ordinator, Professor Julián Panés, Head of the
Inflammatory Bowel Disease Unit at the Hospital Clinic of Barcelona (Spain) and
President of the European Crohn's and Colitis Organization (ECCO), and the
EU/Israel surgeon study coordinator, Dr. Damián García Olmo, Chief of the
Department of Surgery at Fundación Jiménez Díaz University Hospital, Universidad
Autónoma de Madrid (Spain).
The global pivotal Phase III trial is a randomized, double-blind, placebo-
controlled study designed to confirm the efficacy and safety of a single
administration of Cx601 for the treatment of complex perianal fistulas in
Crohn's disease patients. The trial design is similar to the European Phase III
ADMIRE-CD trial for Cx601 with an identical primary endpoint. In January 2017,
the U.S. Food and Drug Administration (FDA) agreed to the design of the protocol
for the global Phase III trial, and confirmed that a future U.S Biologics
License Application (BLA) could be filed based on the study results at week 24,
instead of week 52, from a broader patient population than the initial Special
Protocol Assessment (SPA) formally endorsed in August 2015. With these
adjustments, the trial should benefit from an expedited recruitment process,
leading to shorter timelines, an earlier filing, and the possibility of an
earlier approval in the U.S.
"Investigator meetings are critical to the success of any clinical trial. The
attendance and support from leading experts in the GI field confirms the strong
interest from the medical community in our global phase III trial and,
ultimately, for Cx601 as a potential new treatment for patients," said Dr.
Marie-Paule Richard, Chief Medical Officer at TiGenix.
"Following my participation as Principal Investigator for the European ADMIRE-CD
trial, which successfully met its primary endpoint and safety and efficacy
profile, I am excited to participate in this global trial as study coordinator
for Europe and Israel," said Professor Julian Panés. "We are eager to continue
building on the evidence gained from the ADMIRE-CD trial and, ultimately, to
offer patients a durable cure for their complex perianal fistulas, which remain
a severe and debilitating complication of Crohn's disease."
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 and NASDAQ: TIG) is an advanced biopharmaceutical
company developing novel therapies for serious medical conditions by exploiting
the anti-inflammatory properties of allogeneic, or donor-derived, expanded stem
cells.
TiGenix lead product, Cx601, has successfully completed a European Phase III
clinical trial for the treatment of complex perianal fistulas - a severe,
debilitating complication of Crohn's disease. Cx601 has been filed for
regulatory approval in Europe and a global Phase III trial intended to support a
future U.S. Biologic License Application (BLA) is expected to start in 2017.
TiGenix has entered into a licensing agreement with Takeda, a global
pharmaceutical company active in gastroenterology, under which Takeda acquired
the exclusive right to develop and commercialize Cx601 for complex perianal
fistulas outside the U.S. TiGenix' second adipose-derived product, Cx611, is
undergoing a Phase I/II trial in severe sepsis - a major cause of mortality in
the developed world. Finally, AlloCSC-01, targeting acute ischemic heart
disease, has demonstrated positive results in a Phase I/II trial in acute
myocardial infarction (AMI). TiGenix is headquartered in Leuven (Belgium) and
has operations in Madrid (Spain). For more information, please visit
http://www.tigenix.com.
About Cx601
Cx601 is a local administration of allogeneic (or donor derived) expanded
adipose-derived stem cells (eASCs) for the treatment of complex perianal
fistulas in Crohn's disease patients that have previously failed conventional
therapy. Crohn's disease is a chronic inflammatory disease of the intestine and
complex perianal fistulas are a severe and debilitating complication for which
there is currently no effective treatment. Cx601 was granted orphan drug
designation by the European Commission in 2009. TiGenix completed a European
Phase III clinical trial (ADMIRE-CD) in August 2015 in which both the primary
endpoint and the safety and efficacy profile were met, with patients receiving
Cx601 showing a 44% greater probability of achieving combined remission compared
to control (placebo). A follow-up analysis was completed at 52 weeks and 104
weeks post-treatment, confirming the sustained efficacy and safety profile of
the product. The 24-week results of the Phase III ADMIRE-CD trial were published
in The Lancet in July 2016. Based on the positive 24 weeks Phase III study
results, TiGenix submitted a Marketing Authorization Application to the European
Medicines Agency (EMA) and a decision is expected in 2017. A global Phase III
clinical trial intended to support a future U.S. Biologic License Application
(BLA) is expected to start in 2017, based on a trial protocol that has been
agreed with the Food and Drug Administration (FDA) through a special protocol
assessment procedure (SPA). In July 2016, TiGenix entered into a licensing
agreement with Takeda, a global pharmaceutical company active in
gastroenterology, under which Takeda acquired exclusive rights to develop and
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: 13.06.2017 - 07:00 Uhr
Sprache: Deutsch
News-ID 547499
Anzahl Zeichen: 10243
contact information:
Town:
Leuven
Kategorie:
Business News
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