TiGenix announces approval of trade name for lead development candidate Cx601 in Europe
(Thomson Reuters ONE) -
PRESS RELEASE
TiGenix announces approval of trade name for lead development candidate Cx601 in
Europe
International Nonproprietary Name (INN), darvadstrocel, approved for Cx601
Leuven (BELGIUM) - November 16, 2017, 7h:00 CET - 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, announces today that the
European Medicines Agency's (EMA) Committee for Human Medicinal Products (CHMP)
has approved the company's proposed trade name Alofisel for its proprietary
investigational compound Cx601, a treatment for complex perianal fistulas in
patients with Crohn's disease.
The trade name Alofisel, a registered trademark owned by TiGenix, will be used
from now onwards in the ongoing centralized drug approval process of Cx601 with
the EMA, covering all 28 member states of the EU, plus Norway, Iceland and
Lichtenstein, as well as from the time of launch following marketing
authorization.
TiGenix has also received approval from the United States Adopted Names (USAN)
Council and the International Nonproprietary Names (INN) Expert Group at the
World Health Organization (WHO) for the use of the nonproprietary name
darvadstrocel for Cx601. Darvadstrocel will be included in the forthcoming list
of recommended INNs published by the WHO. INNs are simple, informative and
unique nonproprietary names for drugs based on pharmacological and/or chemical
relationships to allow for clear identification and communication among health
professionals.
TiGenix has submitted a Marketing Authorization (MA) Application for Alofisel to
the EMA for the treatment of complex perianal fistulas in adult patients with
non-active/mildly active luminal Crohn's disease, when fistulas have shown an
inadequate response to at least one conventional or biologic therapy. A CHMP
opinion is expected in 2017.
For more information please contact:
TiGenix
Claudia Jiménez
Senior Director IIRR and Communications
T: +34 91 804 92 64
claudia.jimenez(at)tigenix.com
PR Enquiries
Consilium Strategic Communications
Chris Gardner, Sukaina Virji, Melissa Gardiner
Tel: +44 (0)20 3709 5700
TiGenix(at)consilium-comms.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, 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) and
Cambridge, MA (USA). 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 and by the U.S. Food and Drug
Administration (FDA) in 2017. 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[1] 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[2]. Based on the positive 24 weeks Phase III study results,
TiGenix submitted a Marketing Authorization Application to the European
Medicines Agency (EMA) and a CHMP opinion is expected in 2017. A global Phase
III clinical trial (ADMIRE-CD II) 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) (clinicaltrials.gov; NCT03279081). ADMIRE-CD
II 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. 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.
--------------------------------------------------------------------------------
[1] 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.
[2] 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.
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: 16.11.2017 - 07:00 Uhr
Sprache: Deutsch
News-ID 568407
Anzahl Zeichen: 7858
contact information:
Town:
Leuven
Kategorie:
Business News
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