TiGenix is set for a decisive 2017 with possible EMA approval in H2 of the allogeneic stem cell therapy Cx601 to treat complex perianal fistulas in Crohn’s disease. This will trigger a €15m milestone from Takeda, the European partner; Takeda views Cx601 as a breakthrough therapy. A Phase I/II trial using stem cells to control severe sepsis, a major unmet need, has just started. Another interesting project is on acute cardiac stem cell therapy; Phase I/II data are expected in H117. The US IPO raised €31m net in 2016.
TiGenix’s expanded adipose stem cells trial is the first allogeneic stem cell therapy to have delivered successful Phase III results. Phase III had 212 intention-to-treat (ITT) cases with non-healing complex perianal fistulas: channels linking the lower bowel and rectum to the skin around the anus. In the ITT group, Cx601 at a dose of 120m cells gave combined remission in 49.5% of those treated vs 34.3% in the placebo group at 24 weeks; this was significant, p=0.024. At 52 weeks, 75% of Cx601-treated patients who had been in combined remission at week 24 had not relapsed, compared to 55.9% in the placebo arm. The high rate of prolonged 52-week complete remission is highly encouraging. The global Cx601 trial for FDA submission is expected to start in 2017. There is an agreed SPA and an expedited review may be gained.
In this webcast, managing director and CEO Eduardo Bravo discusses the increasing success of TiGenix based on the landmark treatment, Cx601, which uses stem cells to treat perianal fistulas, a complication of Crohn’s disease and has other potential use in sepsis. The interview highlights the company’s progress over the past 18 months, including the positive Phase III results from autumn 2015 and the mid-2016 partnership with Takeda to commercialise Cx601 in Europe after potential EMA approval. Eduardo also discusses the interest from US investors and the future of TiGenix’s cardiac programme.