TiGenix : reports positive results of Cx621 Phase I
(Thomson Reuters ONE) -
Regulated information
July 2, 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 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.
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
Director Investor & Media Relations
hans.herklots(at)tigenix.com
+32 16 39 79 73
About TiGenix
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.
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#1623077]
Unternehmensinformation / Kurzprofil:
Datum: 02.07.2012 - 07:01 Uhr
Sprache: Deutsch
News-ID 161619
Anzahl Zeichen: 7338
contact information:
Town:
Leuven
Kategorie:
Business News
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