TiGenix receives green light to start Phase I with Cx621

TiGenix receives green light to start Phase I with Cx621

Leuven (BELGIUM) - December 20, 2011 - TiGenix (NYSE Euronext: TIG) announced today that it has obtained all the required approvals to start the company's Phase I clinical trial to assess the safety of intra-lymphatic administration of its expanded adipose stem cells product (Cx621). The Phase I will enroll 10 healthy volunteers and the company expects the last volunteer to be dosed in April, with final results reported by June 2012. Cx621 aims to capitalize on the benefits of TiGenix's proprietary approach of intra-lymphatic administration to treat autoimmune disorders.

"We are delighted that we can start the Phase I trial with Cx621," said Eduardo Bravo, CEO of TiGenix. "We expect that the intra-lymphatic route of administration is not only feasible, but has the potential to become an important alternative next to other administration routes, and may prove to be a very promising new approach in combating autoimmune disorders with expanded allogeneic stem cells."

About Cx621 for autoimmune disorders

Cx621 is an allogeneic eASC product candidate for the treatment of autoimmune diseases via a proprietary technique of intra-lymphatic or intra-nodal administration. The intra-lymphatic route is expected to offer significant benefits, as the systemic effect of the cells has been shown to be mediated at the level of the secondary lymphoid organs, the draining lymph nodes and spleen. Recent preclinical and clinical experience with vaccines and antitumor agents indicate that the lymph nodes may provide a feasible and safe route of administration. Indeed, the subcutaneous lymph nodes are readily visible by ultrasound and injection of a superficial lymph node in the groin area can be performed quickly and without prior training. Patients rated intra-lymphatic injection less painful than venous puncture (Senti et al., 2008).

For more information:

Eduardo Bravo, Chief Executive Officer, eduardo.bravo@tigenix.com
Gil Beyen, Chief Business Officer,gil.beyen@tigenix.com
Hans Herklots,Director Investor & Media Relations,hans.herklots@tigenix.com,+32 16 39 79 73

About TiGenix

TiGenix NV (NYSE Euronext Brussels: TIG) is a leading European cell therapy company with two marketed products, ChondroCelect and ChondroMimetic, 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 facilities in Madrid (Spain), Cambridge (UK) and Sittard-Geleen (the Netherlands). For more information please visit www.tigenix.com.

Forward-looking information

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 recognised 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.