TiGenix NV (TGXSF.PK), an advanced biopharmaceutical company, Thursday announced that the results of its Phase I sepsis challenge trial of Cx611 confirmed safety and tolerability.
Cx611 is an intravenously-administered product of allogeneic expanded adipose-derived stem cells or 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.
According to the firm, 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.
Marie Paule Richard, Chief Medical Officer of TiGenix, said, "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. 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."
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