TiGenix starts Phase I trial of Cx611 in severe sepsis
TiGenix NV announced that the first subject has been entered into its Phase I trial of Cx611 in severe sepsis.
Cx611 is an intravenously-administered product of allogeneic expanded adipose-derived stem cells (eASC's). The product will enter Phase II of clinical development for early rheumatoid arthritis next year, and this study marks the start of its development for patients with severe sepsis. This trial is a proof of principle study and is designed to demonstrate the efficacy of Cx611 in healthy volunteers challenged with a bacterial endotoxin (lipopolysaccharide) which elicits an inflammatory response inducing sepsis-like clinical symptoms. The trial is a placebo-controlled dose-ranging study (3 doses of eASC's) in which 32 healthy male volunteers will be randomised to receive Cx611 or placebo in a ratio of 3:1. Primary endpoints will be vital signs and symptoms, laboratory measures and functional assays of innate immunity.
"The mortality rate for patients with severe sepsis is over 50%", said Dr Marie Paule Richard, Chief Medical Officer of TiGenix. "We believe that by adding Cx611 to the current standard of care, TiGenix can reduce this grave loss of life. TiGenix expects to complete the trial by the third quarter of 2015, and then to follow up with a Phase II trial of Cx611 as an add-on therapy to the standard of care in patients with severe sepsis."
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