TiGenix NV announces it has opened an U.S. office in Cambridge, Massachusetts. Establishing U.S. operations is a significant step for TiGenix and will support its strategic goal of developing and commercializing its lead product, Cx601, for the treatment of complex perianal fistulas in Crohn's disease patients, in the United States.
TiGenix' US operations are based at the Cambridge Innovation Center in Kendall Square, at the epicenter of the Boston-area biotech hub. TiGenix is in the process of appointing a senior team to support the U.S. and Canadian launch of TiGenix' global pivotal Phase III trial for Cx601, which started in Europe and Israel in June 2017, and the upcoming regulatory discussions with the FDA.
TiGenix has already been actively progressing clinical start-up activities in the U.S. and anticipates starting recruitment for the trial in North American centers in H1 2018. The global trial is designed to support a future U.S. Biologics License Application (BLA) to the Food and Drug Administration (FDA) for Cx601 for the treatment of complex perianal fistulas in patients with Crohn's disease. In parallel, TiGenix is also exploring further expedited pathways to accelerate the submission and review process for U.S. approval.
Eduardo Bravo, CEO at TiGenix said: "It is very exciting to be establishing TiGenix at the heart of one of the world's leading biotechnology hubs. We are working hard to progress the development of Cx601 in the U.S. and having a team based in Cambridge will add further momentum to these efforts to bring a new treatment option to U.S patients suffering from this severe and debilitating complication of Crohn's disease."