LEUVEN, BELGIUM and MADRID, SPAIN--(Marketwire -08/08/12)- TiGenix (EURONEXT:TIG), the European leader in cell therapy, announced today the completion of patient enrollment in the Company's Phase IIa study of Cx611, a suspension of expanded allogeneic adult stem cells, in rheumatoid arthritis. The Phase IIa clinical trial is a 53-subject, multicenter, placebo-controlled study in 3 cohorts with different dosing regimens, designed to assess safety, feasibility, tolerance, and optimal dosing. The study is being conducted at 23 centers. The Company believes that this clinical trial can set the stage not only for the further development of Cx611 in RA, but also in a wide range of other autoimmune disorders. "In addition to the primary endpoints of safety and optimal dosing, we expect this trial to yield a first indication of the duration of the efficacy of Cx611 in this very difficult patient population: the enrolled patients have previously failed to respond to at least two biologicals," said Eduardo Bravo, CEO of TiGenix. "In the trial patients are treated with three injections of Cx611. The six-month follow-up without further dosing should provide us with a truly meaningful result. This is the most advanced stem cell therapy trial in RA in the world, and completing … Continue reading
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