TiGenix announces Cx601 meets primary endpoint in pivotal Phase III trial

LEUVEN, Belgium, Aug. 23, 2015 (GLOBE NEWSWIRE) -- TiGenix NV (Euronext Brussels: TIG), an advanced biopharmaceutical company focused on developing and commercialising novel therapeutics from its proprietary platforms of allogeneic expanded stem cells, announced today that its lead compound Cx601 met the primary endpoint in the Phase III ADMIRE-CD trial in Crohn's disease patients with complex perianal fistulas. Cx601 is a suspension of allogeneic expanded adipose-derived stem cells (eASC) injected intra-lesionally. A single injection of Cx601 was statistically superior to placebo in achieving combined remission at week 24, in patients with inadequate response to previous therapies, including anti-TNFs. The study results confirm the favourable safety and tolerability profile of Cx601.

ADMIRE-CD is a randomised, double-blind, placebo-controlled Phase III study designed to confirm the efficacy and safety of a single injection of Cx601 in the treatment of complex perianal fistulas in Crohn's disease patients. In total, 289 patients were recruited across 50 active sites in 7 European countries and Israel. Patients included had an inadequate response to previous therapies, including anti-TNFs. Continuation of medical standard of care was allowed during the duration of the trial in both groups. The study primary endpoint was combined remission at week 24, defined as closure of all treated external openings draining at baseline despite gentle finger compression, and absence of collections >2cm confirmed by MRI[2].

In the ITT[3] population (n=212), Cx601 achieved statistically significant superiority (p<0.025) with 49.5% combined remission at week 24 compared to 34.3% in the placebo arm. In the mITT[4] population (n=204), the combined remission rates at week 24 were 51.5% and 35.6% for Cx601 and placebo, respectively (p<0.025). These results translate into an observed relative risk of 1.44, meaning that patients receiving Cx601 had 44% more chances to achieve combined remission than placebo patients. Efficacy results were robust and consistent across all statistical populations.

Treatment-emergent adverse events (non-serious and serious) and discontinuations due to adverse events were comparable between Cx601 and placebo arms.

"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", said Dr Marie Paule Richard, Chief Medical Officer of TiGenix. "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".

Full efficacy and safety results will be presented at the 11th Congress of ECCO (European Crohn's and Colitis Organisation).

"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", said Dr Julián Panés, Head of the Gastroenterology Department, Head of the Inflammatory Bowel Diseases Unit, and Associate Professor of Medicine at the Hospital Clínic of Barcelona, President-Elect of ECCO, and Chairman of TiGenix ADMIRE-CD Scientific Advisory Board.

"This is a landmark achievement for TiGenix", said Eduardo Bravo, CEO of TiGenix. "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".

Webcast and conference call

On Monday 24 August, at 15:00h CET/9:00h EDT, TiGenix will conduct a conference call and webcast. The following speakers will present the Top-Line results of the trial, explain the next steps for Cx601 and the Company, and will take questions:

  • Mr Eduardo Bravo, Chief Executive Officer of TiGenix

  • Dr Marie Paule Richard, Chief Medical Officer of TiGenix

  • Dr Julián Panés, Head Gastroenterology Department, Head IBD Unit, and Associate Professor of Medicine at Hospital Clínic of Barcelona, President-Elect of ECCO, and Chairman of TiGenix ADMIRE-CD Scientific Advisory Board

- See more at: http://globenewswire.com/news-release/2015/08/23/762658/10146900/en/TiGenix-announces-Cx601-meets-primary-endpoint-in-pivotal-Phase-III-trial.html#sthash.gQov3BDG.hbp0PUMd.dpuf

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