TiGenix : positive interim safety results of Phase IIa rheumatoid arthritis study with allogeneic adult stem cells "Cx611"
(Thomson Reuters ONE) -
Regulated information
December 19, 2012
TiGenix reports positive interim safety results of Phase IIa rheumatoid
arthritis study with allogeneic adult stem cells "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."
For more information:
Eduardo Bravo Claudia D'Augusta
Chief Executive Officer Chief Financial Officer
eduardo.bravo(at)tigenix.com claudia.daugusta(at)tigenix.com
Hans Herklots
hans.herklots(at)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, 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.
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#1666101]
Unternehmensinformation / Kurzprofil:
Datum: 19.12.2012 - 07:01 Uhr
Sprache: Deutsch
News-ID 214165
Anzahl Zeichen: 5635
contact information:
Town:
Leuven
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 217 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"TiGenix : positive interim safety results of Phase IIa rheumatoid arthritis study with allogeneic adult stem cells "Cx611""
steht unter der journalistisch-redaktionellen Verantwortung von
TiGenix (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
