19 December 2012
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.”
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.
This document may contain forward-looking statements and estimates with respect to the anticipated future performance of TiGenix and the market in which it operates. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar expressions. They include all matters that are not historical facts. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond TiGenix’ control. Therefore, actual results, the financial condition, performance or achievements of TiGenix, or industry results, may turn out to be materially different from any future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward looking statements, forecasts and estimates only speak as of the date of the publication of this document. TiGenix disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in TiGenix’ expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement, forecast or estimate is based, except to the extent required by Belgian law.