TiGenix reports positive interim safety results of its Phase IIa study of Cx611
Leuven (BELGIUM), Madrid (SPAIN) – December 19, 2012 – TiGenix (NYSE Euronext: TIG), the European leader in cell therapy, announced today positive interim safety results of its Phase IIa study of Cx611 in rheumatoid arthritis (RA). Cx611 is an intravenously injected suspension of expanded allogeneic adult stem cells derived from human adipose (fat) tissue. 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.
The interim results cover the first three months of the Phase IIa’s six-month follow-up, and the data are still blinded. The primary endpoint of this study is safety, and the data collected so far support the good safety profile of all three doses of Cx611. Only two patients (4%) have suffered serious adverse events and only in one case (2%) it led to discontinuation of the treatment. All other side effects were mild and transient.
“We are delighted to report that the safety profile of Cx611 appears to be excellent,” said Eduardo Bravo, CEO of TiGenix. “We have recruited patients who have failed at least two biologicals. If, in addition to this promising safety data, we can demonstrate a first indication of efficacy in this difficult to treat patient population, we will have a strong rationale to move forward with this product. We are looking forward to reporting the final results of the study at the end of April 2013.”
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TiGenix NV (NYSE Euronext Brussels: TIG) is a leading European cell therapy company with a marketed cell therapy product for cartilage repair, ChondroCelect®, and a strong pipeline with clinical stage allogeneic adult stem cell programs for the treatment of autoimmune and inflammatory diseases. TiGenix is based out of Leuven (Belgium) and has operations in Madrid (Spain), and Sittard-Geleen (the Netherlands). For more information please visit www.tigenix.com.
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