TiGenix to present positive 52-week Phase III Cx601 data at EHA-SWG Scientific Meeting
(Thomson Reuters ONE) -
PRESS RELEASE
TiGenix to present positive 52-week Phase III Cx601 data at EHA-SWG Scientific
Meeting
Leuven (BELGIUM) - November 20, 2017, 07:00h 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, today announces that the
positive 52-week results from its ADMIRE-CD Phase III clinical trial of Cx601
for the treatment of complex perianal fistulas in patients with Crohn's disease
will be presented at the EHA-SWG Scientific Meeting on Shaping the Future of
Mesenchymal Stromal Cells Therapy taking place from November 23-25, 2017 in
Amsterdam, Netherlands. TiGenix is a contributor of the meeting.
Presentation Title:
Allogeneic adipose-derived MSC for complex perianal fistulas in Crohn's disease
Session Date:
Friday, November 24, 2017
Session Time:
13:30 - 15:30 Scientific session: Clinical Trials
Presenter:
Pr. Damian Garcia Olmo, MD
"We are looking forward to presenting positive 52-week results from the ADMIRE-
CD Phase III trial demonstrating the long-term efficacy and safety of Cx601 for
complex perianal fistulas in Crohn's disease patients at this key scientific
meeting," said Dr. Mary Carmen Diez, Vice President, Medical Affairs and
Commercialisation at TiGenix. "These data have been used to support our
marketing authorisation application for Cx601, for which we anticipate a CHMP
opinion in 2017. TiGenix is proud to support this exciting meeting, which brings
together science and clinical research for novel advanced therapy medicinal
products."
For more information please contact:
TiGenix
Claudia Jiménez
Senior Director Investor Relations and Communications
Tel: +34918049264
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 and 104 weeks post-
treatment, confirming the sustained efficacy and safety profile of the
product[i]. The 24-week results of the Phase III ADMIRE-CD trial were published
in The Lancet in July 2016[ii]. 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 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.
--------------------------------------------------------------------------------
[i] 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.
[ii] 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: 20.11.2017 - 09:31 Uhr
Sprache: Deutsch
News-ID 568927
Anzahl Zeichen: 7497
contact information:
Town:
Leuven
Kategorie:
Business News
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