Publication date: 21/11/2017
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.
Allogeneic adipose-derived MSC for complex perianal fistulas in Crohn's disease
Friday, November 24, 2017
13:30 - 15:30 Scientific session: Clinical Trials
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."
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.