TiGenix says additional data for stem cell product affirms safety profile
pharmafile | March 9, 2016 | News story | Research and Development | Crohn’s disease, TiGenix, crohn's disease, drug trial
Belgian biotech firm TiGenix said the results of a 52-week follow-up study of its trial drug for a stem-cell condition for patients with Crohn’s disease confirms the favorable safety and tolerability profile.
The company said Phase III trials for the drug candidate met the primary endpoint 24 weeks into the therapy.
Dr Marie Paule Richard, chief medical officer of TiGenix, said, “We are delighted with the remarkable consistency of these results with respect to those reported at 24 weeks. In particular, the 75% persistence in the combined remission from week 24 to week 52 confirms Cx601 as a promising therapeutic solution for a hard to treat population that is refractory to existing treatments including anti-TNFs. The improvement brought by Cx601 compared to the best standard of care available could make a real difference to the life of patients suffering from this chronic disease”.
TiGenix reported the week 52 data showed a higher rate of sustained closure in those patients treated with Cx601 and in combined remission at week 24 compared to patients in the placebo group.
Dr Julián Panés, chairman of TiGenix Admire-CD Scientific Advisory Board, said, “With a single injection of Cx601 more than 50% of patients are in remission at one year with a favourable safety profile. Remarkably, most patients that were already in remission at six months continue to benefit from the treatment six months later, a major breakthrough in this field.”
The company, in December filed for a listing on the Nasdaq.
Anjali Shukla
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