Leuven, Belgium-based TiGenix is turning to Nasdaq in search of money to bankroll its clinical trial program, the centerpiece of which is a cell therapy treatment of complex perianal fistulas in Crohn's disease patients. Last year, TiGenix generated late-phase data on the product, a suspension of allogeneic expanded adipose-derived stem cells (eASC) called Cx601, to support an imminent filing for approval in Europe. Some of the anticipated IPO haul will go toward building out sales infrastructure in Europe, with another tranche being set aside to move Cx601 into a Phase III trial in the U.S.
TiGenix is hoping the FDA will grant fast-track status to Cx601. And, having spoken to the regulator, the company thinks it may be able to file for approval on the basis of one U.S. Phase III trial and data from the 289-person European study, in which TiGenix calculated that patients receiving Cx601 had a 44% greater chance of achieving combined remission than people in the placebo arm. The plan is to submit an IND to FDA by the end of this year with a view to starting the study early in 2017. TiGenix has agreed on the design of the trial, which has the same endpoint as the European study, with the FDA.
