TiGenix : completes patient enrollment in Phase IIa rheumatoid arthritis study
(Thomson Reuters ONE) -
Regulated information
August 8, 2012
TiGenix completes patient enrollment in Phase IIa rheumatoid arthritis study
Leuven (BELGIUM), Madrid (SPAIN) - August 8, 2012 - TiGenix (NYSE Euronext:
TIG), the European leader in cell therapy, announced today the completion of
patient enrollment in the Company's Phase IIa study of Cx611, a suspension of
expanded allogeneic adult stem cells, in rheumatoid arthritis. 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.
"In addition to the primary endpoints of safety and optimal dosing, we expect
this trial to yield a first indication of the duration of the efficacy of Cx611
in this very difficult patient population: the enrolled patients have previously
failed to respond to at least two biologicals," said Eduardo Bravo, CEO of
TiGenix. "In the trial patients are treated with three injections of Cx611. The
six-month follow-up without further dosing should provide us with a truly
meaningful result. This is the most advanced stem cell therapy trial in RA in
the world, and completing the enrollment on time confirms our leadership
position in the field. We anticipate reporting the results of the study no later
than April 2013."
About Cx611 for rheumatoid arthritis
Cx611 is a suspension of expanded allogeneic adult stem cells 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 has enrolled 53 patients, divided in 3 cohorts with different dosing
regimens. There are 23 centers 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(at)tigenix.com
Claudia D'Augusta
Chief Financial Officer
claudia.daugusta(at)tigenix.com
Hans Herklots
Director Investor & Media Relations
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#1632416]
Unternehmensinformation / Kurzprofil:
Datum: 08.08.2012 - 07:00 Uhr
Sprache: Deutsch
News-ID 172592
Anzahl Zeichen: 6019
contact information:
Town:
Leuven
Kategorie:
Business News
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