TiGenix strengthens European IP protection around lead development program Cx601
(Thomson Reuters ONE) -
PRESS RELEASE
TiGenix strengthens European IP protection around lead development program Cx601
Leuven (BELGIUM) - November 2, 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 announced that it
has further strengthened its IP protection around the company's lead product
Cx601, intended for the treatment of complex perianal fistulas in patients with
Crohn's disease.
The use of Cx601 in treating fistulas is protected by European patent EP
2292737 entitled "Use of adipose tissue-derived stromal stem cells in treating
fistula". The validity of this patent has been found undisputed in an opposition
proceeding before the European Patent Office (EPO) Opposition Division. In
addition, the EPO has also granted TiGenix the divisional European patent EP
2944688 entitled "Use of adipose tissue-derived stromal stem cells in treating
fistula", protecting pharmaceutical compositions comprising Cx601. These two
events provide increased patent protection for the company's lead product.
"The successful outcome of the proceeding against our base Cx601 patent and the
granting of the new European patent further strengthens TiGenix' intellectual
property portfolio in the use of expanded adipose-derived stem cells (eASCs) in
treating fistulas," said Wilfried Dalemans, Chief Technical Officer at TiGenix.
"This patent protection supplements the Orphan Drug Designation for Cx601, which
grants the product 10 years of market exclusivity following marketing approval
in Europe."
Complex perianal fistulas are considered one of the most disabling complications
of Crohn's disease[i] and can cause intense pain[ii], infection and
incontinence.(v) Despite modern and surgical advancements, they currently remain
challenging for clinicians to treat[iii] and have a significant negative impact
patient quality of life.(ii) Cx601, an allogeneic adipose stem cell derived
preparation, has been developed to treat such fistulas.
Cx601 is under review 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. TiGenix has submitted a Marketing Authorization (MA) Application to the
EMA, wherefore a CHMP opinion is expected to be received in 2017. Cx601 has been
licensed to Takeda for the exclusive development and commercialization outside
of the U.S. in the submitted indication.
Cx601 has been granted Orphan Drug status in Europe, Switzerland and in the U.S.
TiGenix has a comprehensive patent portfolio protecting its stem cell therapy
product candidates, including a granted patent for treating fistulas with Cx601
in the U.S.
For more information
Claudia Jiménez
Senior Director, Investor Relations and Communications
Tel: +34918049264
Claudia.jimenez(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
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[iv]. The 24-week results of the Phase III ADMIRE-CD trial were published
in The Lancet in July 2016[v]. 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] Marzo M, Felice C, Pugliese D, et al., Management of perianal fistulas in
Crohn's disease: An up-to-date review. World J Gastroenterol.
2015; 21(5): 1394-1395.
[ii] Mahadev S, Young JM, Selby W, et al., Quality of life in perianal Crohn's
disease: what do patients consider important? Dis Colon Rectum.
2011; 54(5): 579-85
[iii] Geltzeiler C, Wieghard N and Tsikitis V. Recent developments in the
surgical management of perianal fistula for Crohn's disease. Ann Gastroenterol.
2014; 27(4): 320-330.
[iv] 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.
[v] 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: 02.11.2017 - 07:00 Uhr
Sprache: Deutsch
News-ID 566296
Anzahl Zeichen: 9188
contact information:
Town:
Leuven
Kategorie:
Business News
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