Biopharmaceutical company TiGenix NV announced the enrollment of the first participant in their phase 1 study designed to assess Cx611 for treatment of severe sepsis. The trial will help advance the company's development and commercialization of medication using their proprietary allogeneic platform, and expand adipose-derived stem cells (eASC's) for use in treating inflammatory and autoimmune diseases. The drug has already shown promise in curtailing inflammation in Crohn's disease.
The company is evaluating Cx611, which is an intravenously-administered product derived from allogeneic eASC's, in a placebo-controlled dose-ranging study that will enroll 32 healthy male participants. The volunteers will be randomly administrated with either Cx611 or placebo in a 3:1 ratio.
The study was designed by TiGenix NV as a proof of principle investigation to assess the efficacy of Cx611 in healthy patients who are challenged by bacterial endotoxin (lipopolysaccharide), a condition that elicits an inflammatory response inducing sepsis-like clinical symptoms.
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