2 July 2012
TiGenix reports positive results of Cx621 Phase I
Leuven (BELGIUM) – July 2, 2012 – TiGenix (NYSE 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 study
The 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 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 intralymphatic 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.
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 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.