TiGenix strengthens US operations with senior appointments
(Thomson Reuters ONE) -
PRESS RELEASE
TiGenix strengthens US operations with senior appointments
- Dr. Gregory Gordon appointed as Head of Medical Department (U.S.)
- Annette Valles-Sukkar appointed as Associate Director, Clinical Project
Leuven (BELGIUM) - September 12, 2017, 7:00h CEST - TiGenix NV (Euronext
Brussels and NASDAQ: TIG), an advanced biopharmaceutical company exploiting the
anti-inflammatory properties of allogeneic, or donor-derived, stem cells to
develop novel therapies for serious medical conditions, announces today it has
strengthened its U.S. operations with two senior appointments.
Dr. Gregory Gordon has been appointed Head of Medical Department (U.S.) and will
report to Dr. Marie Paule Richard, Chief Medical Officer at TiGenix. Dr. Gordon
has a strong background in clinical and academic medicine and extensive
experience in the pharmaceutical industry driving broad-based, cross-functional
teams in executing all aspects of clinical development. He joins TiGenix from
Nestle Health Science where he was Global Clinical Affairs Lead,
Gastrointestinal Health. In this role he helped design a pharmaceutical
development strategy for gastroenterology and oversaw clinical development
programs in the GI field. He previously held roles at Stealth BioTherapeutics,
Inc., Ironwood Pharmaceuticals, and Parexel International. Dr. Gordon was
awarded his MD by the State University of New York at Stony Brook School of
Medicine and is a qualified lawyer and member of the New York State Bar.
Annette Valles-Sukkar has been appointed Associate Director, Clinical Project
and will also join Dr. Richard's team. Ms Valles-Sukkar has a successful track
record in the clinical research industry and joins TiGenix from Alexion
Pharmaceuticals, where she was responsible for all aspects of clinical trial
development including management of a global Phase III clinical trial in
neurology. Annette previously held a number of clinical development roles across
a range of indications and technology areas, leading multiple global clinical
trials from Phase I through Phase III and to successful completion. Ms Valles-
Sukkar was awarded a Masters in Health Policy from Northeastern University,
Bouve College of Health Sciences in Boston, MA.
Dr. Marie Paule Richard, Chief Medical Officer at TiGenix said: "We are
delighted to welcome Gregory and Annette to TiGenix and to further build the
team at our U.S. headquarters in Cambridge, MA. Gregory has exceptional
experience in drug development generally and specifically with gastrointestinal
products. Annette has proven ability to manage large-scale late-stage clinical
trials. Together with the rest of the TiGenix team, I am confident both will
make significant contributions as we continue to work hard on the development of
Cx601 in the U.S. for the treatment of patients suffering from complex perianal
fistulas and in other indications in the future."
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. The 24-week data were
published in the Lancet and showed both the primary endpoint and the safety and
efficacy profile were met.[i] A follow-up analysis was completed at 52 weeks and
104 weeks post-treatment, confirming the sustained efficacy and safety profile
of the product.[ii] The 24-week results of the Phase III ADMIRE-CD trial were
published in The Lancet in July 2016.(i )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.
--------------------------------------------------------------------------------
[i] Panés J, García-Olmo D, Van Assche G et al., Expanded allogeneic adipose-
derived mesenchymal stem cells (Cx601) for complex perianal fistulas in Crohn's
disease: a phase 3 randomized, double-blind controlled trial. The Lancet.
2016; 388(10051):1281-90.
[ii] Panes, J. et al., OP009 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 randomised controlled trial.
J Crohn's Colitis. 2017; 11: S5-S5.
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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