Publication date: 05/10/2017
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 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.
"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."
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.