ABLYNX INITIATES PHASE II CLINICAL TRIAL FOR TTP
(Thomson Reuters ONE) -
GHENT, Belgium, 30 September 2010 - Ablynx [Euronext Brussels: ABLX] today
announced that it has opened recruitment in its first clinical trial centre for
an open-label, randomised Phase II study for patients with acquired thrombotic
thrombocytopenic purpura (TTP). This Phase II study will be conducted in Europe
and North America and it is planned to enroll over 100 patients. Ablynx's
anti-von Willebrand factor (vWF) Nanobody(®) was granted orphan drug designation
for the treatment of TTP in May 2009, by both the U.S. Food and Drug
Administration and the European Commission.
During the Phase II study, the Nanobody will be administered to TTP patients as
an adjunct to standard plasma exchange therapy. The primary endpoint of the
study will be the time to response, defined by the normalisation of platelet
count and the blood marker lactate dehydrogenase (LDH). The study goal is to see
a significant reduction in the time to response for the anti-vWF treated
population compared with placebo treatment. It is anticipated that this could
translate into a shorter duration of life-threatening episode, a reduction of
the number of plasma exchanges required and the amount of plasma product
administered.
Dr Edwin Moses, CEO and Chairman of Ablynx commented: "There is currently no
drug treatment approved specifically for TTP. Patients are often hospitalised
for up to two weeks and have to receive frequent plasma exchanges which are
costly and can lead to serious side effects such as allergic reactions or
infections. Despite the plasma exchange treatment, the condition is very serious
with up to 20% mortality. We believe that our anti-vWF Nanobody may reduce the
number of days a TTP patient is hospitalised for plasma exchange thereby
reducing the overall number of plasma transfusions and increasing the quality of
life for these patients." He added: "This is the third Nanobody programme
entering Phase II clinical trials."
For more information, please contact Ablynx:
Dr. Edwin Moses
Chairman and CEO
t: +32 (0)9 262 00 07
m: +44 (0)7771 954 193 / +32 (0)473 39 50 68
e: edwin.moses(at)ablynx.com
Eva-Lotta Allan
Chief Business Officer
t: +32 (0)9 262 00 75
m: +32 (0)475 78 36 21 / +44 (0)7990 570 900
e: eva-lotta.allan(at)ablynx.com
[HUG#1448154]
Complete version of the press release:
http://hugin.info/137912/R/1448154/390534.pdf
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originality of the information contained therein.
Source: Ablynx via Thomson Reuters ONE
Unternehmensinformation / Kurzprofil:
Datum: 30.09.2010 - 18:00 Uhr
Sprache: Deutsch
News-ID 43686
Anzahl Zeichen: 0
contact information:
Town:
Ghent
Kategorie:
Business News
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