TiGenix NV (NYSE Euronext: TIG) is a leading European cell therapy company with an advanced clinical stage pipeline of adult stem cell programmes, and a commercialised product. The stem cell programmes are based on proprietary validated platforms of allogeneic expanded stem cells targeting autoimmune, inflammatory and heart diseases. Built on solid pre-clinical and CMC packages, they are being developed in close consultation with the European Medicines Agency.
Cx601 is in Phase III to treat complex perianal fistulas in patients with Crohn’s disease. The product has met the primary endpoint of this trial at Week 24 of treatment which will allow for filing for European marketing authorisation in the first quarter of 2016. Cx611 has successfully concluded a Phase IIa trial in rheumatoid arthritis, and is now in development for early rheumatoid arthritis and for severe sepsis.
Effective as of July 31, 2015, TiGenix acquired Coretherapix, whose lead cardiac stem cell product (AlloCSC-01) is currently in a Phase II clinical trial in acute myocardial infarction (AMI). Additional planned projects are the clinical evaluation of AlloCSC-01 in the chronic setting, and the pre-clinical development of a pharmaceutical formulation of growth factors to treat AMI.
The company’s commercialised product, ChondroCelect®, for cartilage repair in the knee, was the first cell-based product approved in Europe, and is marketed and distributed by Swedish Orphan Biovitrum AB (‘Sobi’, NASDAQ OMX Stockholm: SOBI) and Finnish Red Cross Blood Service (FRCBS).
TiGenix is based in Leuven, Belgium, and has operations in Madrid , Spain.