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TiGenix

TiGenix is a European cell therapy company with a proprietary validated allogeneic expanded adipose-derived stem cell (eASC) platform technology for the treatment of autoimmune and inflammatory diseases, and a commercialised product. Its corporate headquarters are in Leuven, Belgium, and it has operations in Madrid, Spain. TiGenix was founded in 2000 by Prof. Dr. Frank P. Luyten and Gil Beyen as a spin-off from the Katholieke Universiteit Leuven and the Universiteit Gent.

TiGenix's therapeutic approach is to focus on the use of living cells rather than conventional drugs for the treatment of inflammatory and autoimmune diseases, through its eASC-based platform, and heart disease, through its CSC-based platform. TiGenix's pipeline of stem cell programs is based on validated platforms of allogeneic stem cells.

As of March 31, 2016, TiGenix's pipeline portfolio was the most advanced cell therapy platform in Europe, with positive pivotal Phase III data for its lead product candidate and three further product candidates in Phases II and I and pre-clinical development.

TiGenix has completed, and received positive data in, a single pivotal Phase III trial in Europe of its most advanced product candidate Cx601, a potential first-in-class injectable allogeneic stem cell therapy indicated for the treatment of complex perianal fistulas in patients suffering from Crohn's disease. On July 28, 2016 The Lancet published the 24-Week Results of the Phase 3 ADMIRE-CD Trial Investigating Cx601 in the Treatment of Complex Perianal Fistulas in Patients with Crohn’s Disease.

Cx601 has been granted orphan designation by the European Medicines Agency in recognition of its potential application for the treatment of anal fistulas, which affect approximately 120,000 adult patients in the United States and Europe and for which existing treatment options are inadequate.

TiGenix developed and commercialized ChondroCelect, the first cell-based medicinal product to receive marketing authorization from the EMA, which was indicated for cartilage repair in the knee. In July 2016, TiGenix requested the withdrawal of its marketing authorization for ChondroCelect.