Eyeing the U.S. market, TiGenix touts 52-week data from PhIII stem cell trial

Belgian biotech TiGenix claimed a rare Phase III win for a stem cell product last year when it reported that its lead program hit the primary endpoint among patients with Crohn's disease 24 weeks after therapy. And now it says the 52-week follow-up continued to reflect the treatment's success as it angles for a $57 million IPO on Nasdaq and a late-stage R&D drive in the U.S.

By the numbers: 54.2% of patients who had a single injection of Cx601 to treat fistulas in Crohn's disease patients were in remission after a year, compared to 37.1% of the placebo arm. Three out of four patients--75%--of the patients in remission 24 weeks after treatment with the stem cell therapy remained in remission after a year, compared to 55.9% of the placebo arm.

All the patients recruited for the study were resistant to currently used drugs. Cx601 uses off-the-shelf stem cells extracted from fat and injected intralesionally.

The data fit the pattern the biotech touted as it filed for a $57 million IPO. And it marked an uncommon advance for a stem cell therapy--a once-lauded field that has fallen on hard times as treatments either foundered in the clinic or took longer than expected during the frenzy for stem cell treatments a decade ago.

TiGenix is already on the market in Europe (EBR:TIG), where it saw an 8% rise in its share price after the data were released.

The biotech has already filed for a European approval and says it's on track to launch a Phase III program in the U.S. Whether the biotech can raise money on Nasdaq, with low-profile biotechs as well as stem cell therapies out of favor with investors, remains to be seen. TiGenix has a follow-up stem cell program in the clinic for severe sepsis.

- here's the release