TiGenix : rheumatoid arthritis Phase IIa study successfully passes last safety hurdle

Tue Apr 17, 2012 1:01am EDT

* Reuters is not responsible for the content in this press release.

Regulated information
april 17, 2012

TiGenix rheumatoid arthritis Phase IIa study successfully passes last safety hurdle

Leuven (BELGIUM), Madrid (SPAIN) - April 17, 2012 - TiGenix (NYSE Euronext: TIG) announced today that upon review of the safety data of the first three patients of the third cohort of the company's Phase IIa clinical trial in rheumatoid arthritis (Cx611) it has received the go-ahead from the independent Safety Monitoring Board to recruit and dose the remaining patients of this cohort. The Phase IIa trial is based on a three-step dose-finding protocol, where each step starts with a safety review of the first three patients after 40 days of dosing.

"With this last step, we have reached a key milestone in our Phase IIa trial in RA," said Eduardo Bravo, CEO of TiGenix. "The fact that the highest dose has proven safe is of major importance. In RA it ensures that we will not be held back by any dose-limiting factors and we will be able to move forward with the optimal treatment dose. But of almost equal importance is that, if required, we can expand the dosing range in other indications that we are exploring as well. With 6 months of follow-up, the current RA trial in 53 patients is expected to report meaningful results in H1 2013."

About Cx611 for rheumatoid arthritis
Cx611 is a suspension of expanded allogeneic adult stem cell product derived from human adipose (fat) tissue (expanded Adipose derived Stem Cells or 'eASCs') that is delivered through intra-venous injection for the treatment of rheumatoid arthritis. The objective of the Phase IIa trial is to determine safety, feasibility, tolerance, and optimal dosing. This multicentre, placebo-controlled study will involve 53 patients, divided in 3 cohorts with different dosing regimens. There are more than 20 centres open and the company expects the final results to be available in the first half of 2013.

For more information:
Eduardo Bravo
Chief Executive Officer
eduardo.bravo@tigenix.com 

Claudia D'Augusta
Chief Financial Officer
claudia.daugusta@tigenix.com
                         
Hans Herklots
Director Investor & Media Relations
hans.herklots@tigenix.com
+32 16 39 60 97

About TiGenix

TiGenix NV (NYSE Euronext Brussels: TIG) is a leading European cell therapy company with a marketed product for cartilage repair, ChondroCelectR , 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.

 

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.




This announcement is distributed by Thomson Reuters on behalf of Thomson Reuters clients.

The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and other applicable laws; and
(ii) they are solely responsible for the content, accuracy and originality of the
information contained therein.

Source: TiGenix via Thomson Reuters ONE

HUG#1602657
Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.