Stem cell product meets primary end point in Phase III Crohn’s disease trial
TiGenix (Cambridge, UK) has announced that Cx601, its allogeneic expanded adipose-derived stem cell product, met its primary end points in a key Phase III clinical trial
ADMIRE-CD is a randomized, double-blind, placebo-controlled Phase III study carried out by TiGenix (Cambridge, UK) in order to confirm the efficacy and safety of a single injection of Cx601 in the treatment of complex perianal fistulas in Crohn’s disease patients. Cx601 is a suspension of allogeneic expanded adipose-derived stem cells (eASC) injected intralesionally.
TiGenix has announced that Cx601, its lead compound, met the primary end point in the investigation, confirming the product’s positive safety and tolerability. “We are extremely excited about the results of Cx601 in this severely debilitating and difficult to treat condition. Achieving more than 50% combined remission in patients who have not responded adequately to previous treatments, including anti-TNFs, is a remarkable accomplishment”, Dr Marie Paule Richard, Chief Medical Officer of TiGenix, commented. “We are committed to submit these data to the EMA and to bring this innovative new treatment to patients whose life is impacted by the challenges of this serious condition”.
A total of 289 people were recruited to the trial, which took place in Israel and seven European countries, in 50 active sites. The patients had previously had an inadequate response to therapies such as anti-TNFs, and continuation of medical standard of care was permitted all through the trial. The study primary end point was combined remission at week 24, and was characterized as closure of all treated external openings draining at baseline despite gentle finger compression, and absence of collections less than 2 cm confirmed by MRI[2].
Explaining the significance of the results, Dr Julián Panés, Head of the Gastroenterology Department, Head of the Inflammatory Bowel Diseases Unit, and Associate Professor of Medicine at the Hospital ClÃnic of Barcelona, and Chairman of TiGenix ADMIRE-CD Scientific Advisory Board, stated: “The results of this large robust controlled study are clinically relevant and open a completely new avenue for the treatment of perianal fistulising Crohn’s disease, one of the most severe manifestation of this process. The therapy affords a 44% increased chance for patients of closing their fistula with a single injection, which is a major breakthrough.”
Full efficacy and safety results will be presented at the 11th Congress of ECCO — Inflammatory Bowel Diseases 2016. “This is a landmark achievement for TiGenix”, stated Eduardo Bravo, TiGenix’s CEO. “These positive results, together with the recent endorsement by the FDA of our Phase III trial design for the US, let us move full steam ahead making Cx601 available to the more than 100,000 patients who every year suffer from this serious condition”.
Sources: press release: http://www.nasdaq.com/press-release/tigenix-announces-cx601-meets-primary-end point-in-pivotal-phase-iii-trial-20150823-00006#ixzz3jv62xnMi; NCT clinical trial: https://clinicaltrials.gov/ct2/show/NCT01541579?term=admire-cd&rank=1