TiGenix

Safety and tolerability of Cx611 confirmed in Phase I sepsis challenge trial

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PRESS RELEASE

Safety and tolerability of Cx611

confirmed in Phase I sepsis challenge trial

Leuven (BELGIUM) - 28 May, 2015 - TiGenix NV (Euronext Brussels: TIG), an advanced biopharmaceutical company focused on developing and commercialising novel therapeutics from its proprietary platform of allogeneic, expanded adipose-derived stem cells in inflammatory and autoimmune diseases, announced today that the results of its Phase I sepsis challenge trial of Cx611 confirm safety and tolerability.

"The results of this Phase I proof of principle study demonstrate the favorable safety and tolerability profile of Cx611, which is consistent with our previous study in patients with rheumatoid arthritis" said Dr Marie Paule Richard, Chief Medical Officer of TiGenix. "No serious adverse events were reported with any of the three doses tested. With respect to anti-inflammatory activity, no significant effect of Cx611 on the lipopolysaccharide-induced symptoms could be detected."

"The timeframe of this particular lipopolysaccharide challenge model in healthy volunteers might have been too short to allow Cx611 to exert its therapeutic effect" said Dr Wilfried Dalemans, Chief Technical Officer of TiGenix. "Compared to this challenge model, patients suffering from severe sepsis display a much higher level and persistence of inflammation that is expected to provide the necessary signals for the activation of Cx611 and thereby positively interfere with the underlying inflammatory process." TiGenix, along with its Clinical Advisory Board, is further analysing the data to incorporate them into its future developments.

Cx611 is an intravenously-administered product of allogeneic expanded adipose-derived stem cells (eASCs). Its efficacy in significantly reducing mortality has been demonstrated in several animal models of sepsis through a combination of reduced inflammation, production of anti-microbial effectors, and increased phagocytosis. This Phase I trial was a proof of principle study designed to demonstrate the safety and the ability of Cx611 in modifying the inflammatory response in healthy volunteers challenged with a bacterial endotoxin. The trial was a placebo-controlled, parallel group study in which 32 healthy male volunteers were randomised to receive Cx611 (at 3 doses) or placebo in a ratio of 3:1 and followed for 24 hours.