TiGenix opens US headquarters in Cambridge, MA
(Thomson Reuters ONE) -
PRESS RELEASE
TiGenix opens US headquarters in Cambridge, MA
* Decision follows NASDAQ IPO in 2016 and the launch of the global phase III
trial for Cx601
* Operations to be based in Cambridge at heart of Boston area biotech hub
* High-level team of professionals being recruited to support clinical and
regulatory operations in the US
Leuven (BELGIUM) - June 29, 2017, 11:30h 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 it has
opened an U.S. office in Cambridge, Massachusetts. Establishing U.S. operations
is a significant step for TiGenix and will support its strategic goal of
developing and commercializing its lead product, Cx601, for the treatment of
complex perianal fistulas in Crohn''s disease patients, in the United States.
TiGenix'' US operations are based at the Cambridge Innovation Center in Kendall
Square, at the epicenter of the Boston-area biotech hub. TiGenix is in the
process of appointing a senior team to support the U.S. and Canadian launch of
TiGenix'' global pivotal Phase III trial for Cx601, which started in Europe and
Israel in June 2017, and the upcoming regulatory discussions with the FDA.
TiGenix has already been actively progressing clinical start-up activities in
the U.S. and anticipates starting recruitment for the trial in North American
centers in H1 2018. The global trial is designed to support a future U.S.
Biologics License Application (BLA) to the Food and Drug Administration (FDA)
for Cx601 for the treatment of complex perianal fistulas in patients with
Crohn''s disease. In parallel, TiGenix is also exploring further expedited
pathways to accelerate the submission and review process for U.S. approval.
Eduardo Bravo, CEO at TiGenix said: "It is very exciting to be establishing
TiGenix at the heart of one of the world''s leading biotechnology hubs. We are
working hard to progress the development of Cx601 in the U.S. and having a team
based in Cambridge will add further momentum to these efforts to bring a new
treatment option to U.S patients suffering from this 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) started 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) started 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
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Datum: 29.06.2017 - 05:30 Uhr
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