LEUVEN, BELGIUM--(Marketwire -07/02/12)- TiGenix (EURONEXT:TIG) announced today that it has successfully completed the company's Phase I clinical trial to assess the safety of intra-lymphatic administration of its expanded adipose stem cells product (Cx621). Cx621 aims to capitalize on the benefits of TiGenix's proprietary approach of intra-lymphatic administration to treat autoimmune disorders.

The confirmation of the safety of intra-lymphatic administration of TiGenix's expanded adipose stem cells (eASCs) has potentially important clinical and commercial implications. It opens up the possibility of achieving efficacy at much lower dosage, which would further increase the safety profile of TiGenix's eASCs, while it would simultaneously significantly reduce the cost of goods (COGS) and improve margins. An additional benefit is that the subcutaneous lymph nodes are superficial and readily visible by ultrasound, and thus allow for a rapid and easy injection.

"We are delighted to have demonstrated the feasibility and safety of intra-lymphatic administration of our stem cell product," said Eduardo Bravo, CEO of TiGenix. "The validation of this new route of administration reinforces TiGenix's leadership position in the field of stem cell treatments for autoimmune diseases."

About the studyThe Cx621 Phase I placebo-controlled trial evaluated two different cell doses in ten healthy volunteers, five males and five females. Physical, analytical and also morphological measures were included. The ten volunteers were randomly assigned to the two cohorts. After treatment of the first volunteer in each cohort and confirmation of tolerability, the remaining volunteers for each cohort were randomized 1:1 to receive Cx621 or placebo. The study treatment consisted of two administrations one week apart, two lymphatic injections each, one in the left and one in the right inguinal lymph node. Volunteers were followed-up during 21 days after treatment to establish safety and tolerability of the treatment.

The final report of the Cx621 Phase I clinical trial confirms that there were no severe adverse events. Reported adverse events were mild and transient, and not related to the study medication. All changes in vital signs and blood analysis tests were within the normal limits. Imaging ecographic data showed increased lymph node size after administrations, with no clinical or symptomatic effect. Visual Analogic Scale (VAS) for pain produced no significant changes in any volunteer. Some subjective, short-lived "sensations" around the injected inguinal zone occurred more frequently in the placebo arm.

About Cx621 for autoimmune disordersCx621 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 believed 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. TiGenix has filed patents applications for this unique and innovative route of administration.

About TiGenixTiGenix NV (EURONEXT: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 http://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.

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TiGenix Reports Positive Results of Cx621 Phase I

Scientists have for the first time watched and manipulated stem cells as they regenerate tissue in an uninjured mammal, Yale researchers report July 1 online in the journal Nature.

Using a sophisticated imaging technique, the researchers also demonstrated that mice lacking a certain type of cell do not regrow hair. The same technique could shed light on how stem cells interact with other cells and trigger repairs in a variety of other organs, including lung and heart tissue.

This tells us a lot about how the tissue regeneration process works, said Valentina Greco, assistant professor of genetics and of dermatology at the Yale Stem Cell Center, researcher for the Yale Cancer Center and senior author of the study.

Greco and her team focused on stem cell behavior in the hair follicle of the mouse. The accessibility of the hair follicle allowed real-time and non-invasive imaging through a technology called 2-photon intravital microscopy.

Using this method, Panteleimon Rompolas, a post-doctoral fellow in Grecos lab and lead author of this paper, was able to study the interaction between stem cells and their progeny, which produce all the different types of cells in the tissue. The interaction of these cells with the immediate environment determines how cells divide, where they migrate and which specialized cells they become.

The technology allowed the team to discover that hair growth in mice cannot take place in the absence of connective tissue called mesenchyme, which appears early in embryonic development.

Stem cells not only spur growth of hair in mammals including humans, but also can serve to regenerate many other types of tissues.

Understanding how stem cell behavior is regulated by the microenvironment can advance our use of stem cells for therapeutic purposes and uncover mechanisms that go wrong in cancer and other diseases, Greco said.

The study was funded by an Alexander Brown Coxe postdoctoral fellowship. This work was supported in part by the American Skin Association and the American Cancer Society and the Yale Rheumatologic Disease Research Core Center and the National Institutes of Health.

Other Yale authors include Elizabeth Deschene, Giovanni Zito, David G. Gonzalez, Ichiko Saotome and Ann M. Haberman.

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In real time, Yale scientists watch stem cells at work regenerating tissue