TiGenix to present positive 52-week Phase III results of Cx601 at World Congress of Gastroenterology at ACG 2017 meeting
(Thomson Reuters ONE) -
PRESS RELEASE
TiGenix to present positive 52-week Phase III results of Cx601 at World Congress
of Gastroenterology at ACG 2017 meeting
Leuven (BELGIUM) - October 5, 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
has been selected for an oral presentation at the World Congress of
Gastroenterology at the American Congress of Gastroenterology 2017 Annual
Scientific Meeting (WCOG/ACG) taking place from October 13-18, 2017 in Orlando,
Florida, USA.
Oral Presentation
Title: Paper 82: One-year Efficacy and Safety of a Single Dose of
Cx601, Allogeneic Expanded Adipose-Derived Mesenchymal Stem
Cells, for Complex Perianal Fistulas in Crohn's Disease: Long-
Term Results of a Phase 3, Randomized, Double-Blind Clinical
Trial
Session Date: Wednesday, October 18, 2017
Session Time: 10:00am - 10:10am (EDT)
Presenter: Daniel C. Baumgart, MD, PhD
"We are pleased that the positive 52-week results from the ADMIRE-CD Phase III
trial demonstrating the long-term efficacy and safety of Cx601 for treatment-
refractory complex perianal fistulas in Crohn's disease patients has been
selected for an oral presentation at the WCOG/ACG meeting," said Dr. Mary Carmen
Diez, Vice President, Medical Affairs and Commercialisation at TiGenix. "These
data have been used to further support our marketing authorisation application
for TiGenix, for which we anticipate a CHMP opinion in 2017. In parallel, we
continue to progress our global pivotal Phase III trial for a future filing in
the US."
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) 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 or
biologic 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 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). 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] 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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