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Ablynx Initiates Phase II
Clinical Trial For ALX-0081
GHENT, Belgium, 1 September 2009 - Ablynx [Euronext Brussels: ABLX] today
announced the initiation of a Phase II study for its anti-thrombotic Nanobody®
ALX-0081, a first-in-class Nanobody® targeting von Willebrand Factor (vWF).
The open-label, randomized Phase II study is designed to evaluate the safety and
efficacy of multiple doses of ALX-0081 versus the GPIIb/IIIa inhibitor ReoPro®
in patients undergoing percutaneous coronary intervention (PCI). Patients with
unstable angina or patients with stable angina with at least two factors
indicating high risk will be included in this study. ALX-0081 or ReoPro® will be
added to a standard anti-thrombotic regimen including aspirin, heparin and
Plavix®. This multi-institutional, pan-European Phase II study is planned to
enroll close to 370 patients.
Ablynx recently concluded a successful ALX-0081 Phase Ib study in patients with
stable angina undergoing a planned PCI procedure. The drug’s biological effect
was determined using a biomarker, indicating the complete inhibition of vWF and
its mediated effect on platelet aggregation and clotting in coronary arteries.
ALX-0081 showed an excellent efficacy and safety profile in this patient study.
In order to gain additional information on optimal dosing and scheduling, Ablynx
has extended this Phase Ib study to look in more detail at biological markers,
optimization of concurrent treatment with the standard anti-thrombotic regimen,
tolerance and administration. Data from this Phase Ib study extension will be
reported in a few months.
“Initiation of Phase II clinical development of ALX-0081 is a major milestone
for Ablynx,” commented Edwin Moses, CEO and Chairman. “This study builds on our
recent rapid progress and success, generating encouraging safety and efficacy
data in patients. ALX-0081 has the potential to become a safe, first-in-class
anti-platelet agent. We are delighted that the first patient in this important
study was treated in Aalst, Belgium.”
There are currently three Nanobodies® in clinical development of which ALX-0081
is the most advanced. Ablynx’s ALX-0681, also an anti-thrombotic but with a
subcutaneous route of administration, is currently in Phase I in healthy
volunteers. The third Nanobody® is in development with Wyeth Pharmaceuticals
targeting tumor necrosis factor alpha (TNF-alpha), which entered Phase I in
December 2008. Ablynx believes Wyeth may initiate a Phase II proof-of-concept
study in patients with rheumatoid arthritis with its licensed anti-TNF-alpha
Nanobody®, which will trigger a milestone for the Company.
-ends-
About ALX-0081 and ALX-0681
ALX-0081 and ALX-0681 are novel “first-in-class” therapeutic Nanobodies®
targeting von Willebrand factor ("vWF"), a protein found in the blood that acts
at a very early stage in the coagulation cascade, namely platelet adhesion, in
contrast to currently available anti-platelet drugs which act only in the late
stage of platelet aggregation. ALX-0081 is administered intravenously while
ALX-0681 is administered subcutaneously. ALX-0081 is a bivalent Nanobody® with a
molecular weight of 28,000 daltons, designed to selectively prevent unwanted
thrombus formation in vessels under high shear conditions without interfering
with desirable haemostasis and, as such, to minimize bleeding complications.
ALX-0681 reached orphan drug designation in May 2009 and is currently being
developed for TTP.
About the Thrombosis Market
Ablynx believes that ALX-0681 and ALX-0081 target a key opportunity in the anti-thrombotic
market as they may provide a solution to the cardiologist’s current dilemma in
acute coronary syndrome (ACS) which typically involves achieving a balance
between the prevention of unwanted blood clots and potentially life-threatening
bleeding complications. ALX-0081 and ALX-0681 could potentially prevent arterial
thrombosis following angioplasty, which is a serious clinical problem. Other
potential indications for ALX-0081 and ALX-0681 include thrombotic
thrombocytopenic purpura (TTP), myocardial infarction (MI) and stroke.
About Acute Coronary Syndrome (ACS)
ACS is expected to afflict approximately 2.9 million people in the Unites
States, Japan and certain European countries in 2009 according to Datamonitor’s
Pipeline Insight: Antithrombotics, Reaching the untreated prophylaxis market
report, DMHC2284 March 2007, and is the leading cause of mortality in the area
of cardiovascular disease. Experts believe that the prevalence and incidence of
acute infarcts due to arteriosclerosis will increase further, due to the ageing
population. Peripheral artery occlusive disease (PAOD) will affect an estimated
22.1 million individuals in the US, Japan and certain European countries in 2009
and is associated with significant morbidity and mortality.
About Percutaneous Coronary Intervention (PCI)
The term percutaneous coronary intervention (sometimes called PTCA, angioplasty
or stenting) describes a range of procedures that treat narrowing or blockages
in coronary arteries supplying blood to the heart. Many patients undergoing this
procedure will have previously had cardiac catheterisation (sometimes called
coronary angiography) to examine the condition of the coronary vessels.
Alternatively, percutaneous coronary intervention may be undertaken immediately
after the diagnostic angiogram. Most patients with angina can be helped
substantially by coronary stenting. For some patients with very mild disease
stents are not required and medication is sufficient. For a small number of
people bypass surgery is necessary. Almost all stent procedures are successful
and completed in < 2 hours. Inevitably however there are risks and it is
important that patients understand these risks before accepting treatment.
Source:
http://www.thecardiologist.co.uk/coronary.htm
About Thrombotic Thrombocytopenic Purpura (TTP)
TTP is a disease related to the formation of white clots. The underlying
abnormality in TTP is the formation of small platelet clots, which leads to
occlusions of small vessels throughout the body particularly within blood
vessels supplying the brain and the kidneys. It has been shown that these small
platelet clots are caused by the presence of large clusters or strings of
activated vWF. Approximately four cases of TTP per million inhabitants are
diagnosed per year in Europe and the United States. This incidence estimate
suggests that orphan drug designation should be achievable for this indication,
which would enable an accelerated development and approval timetable. There is
currently no approved drug therapy for TPP and plasma exchange is the only
available treatment for these patients today. Plasma exchange involves the
removal of the patient’s plasma (the non-cellular component of blood) and its
replacement by donor plasma. TTP remains a condition with extremely high
morbidity and mortality, even with timely plasma exchange, and so there is still
a significant unmet medical need for this disease.
About Ablynx [Euronext Brussels: ABLX] -
http://www.ablynx.com
Founded in 2001 in Ghent, Belgium, Ablynx is a biopharmaceutical company focused
on the discovery and development of Nanobodies®, a novel class of therapeutic
proteins based on single-domain antibody fragments, for a range of serious and
life-threatening human diseases. The Company currently has over 220 employees.
Ablynx completed a successful IPO on Euronext Brussels [ABLX] on 7 November
2007.
Ablynx is developing a portfolio of Nanobody®-based therapeutic programmes in a
number of major disease areas, including inflammation, thrombosis, oncology and
Alzheimer’s disease. Nanobodies® have been generated against more than 150
different disease targets. Importantly the Nanobodies® which naturally exist in
llamas have a very high homology with humans. Efficacy data has been obtained in
over 26 in vivo models for Nanobodies® against a range of different targets.
Ablynx has an extensive patent position in the field of Nanobodies® for
healthcare applications. It has exclusive and worldwide rights to more than 50
families of granted patents and pending patent applications, including the
Hamers patents covering the basic structure, composition, preparation and uses
of Nanobodies®.
Ablynx has ongoing research collaborations and significant partnerships with
several major pharmaceutical companies, including Boehringer Ingelheim, Merck
Serono, Novartis and Wyeth Pharmaceuticals. Ablynx is building a diverse and
broad portfolio of therapeutic Nanobodies® through these collaborations as well
as through its own internal discovery programmes.
The Company’s lead programme, ALX-0081, an intravenously administered novel
anti-thrombotic has entered Phase II in patients undergoing percutaneous
coronary intervention (PCI). ALX-0681, also an anti-thrombotic but with a
subcutaneous route of administration has concluded a Phase I study in healthy
volunteers. Ablynx has progressed ALX-0141, an anti-RANKL Nanobody® for bone
disorders into preclinical development and aims to initiate a Phase I study
before the end of 2009. ALX-0061, an anti IL6R Nanobody® is in preclinical
development for the treatment of autoimmune and inflammatory diseases. In
addition, Ablynx’s partner Wyeth Pharmaceuticals is currently in Phase I study
with an anti-TNF-alpha Nanobody®.
Nanobody® is a registered trademark of Ablynx NV.
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@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@ablynx.com
For international media enquiries: College Hill Life Sciences
Sue Charles,
Justine Lamond,
Dr. John McIntyre
t: +44 (0)20 7866 7857
e: ablynx@collegehill.com
Certain statements, beliefs and opinions in this press release are
forward-looking, which reflect the Company’s or, as appropriate, the Company’s
directors’ current expectations and projections about future events. By their
nature, forward-looking statements involve a number of risks, uncertainties and
assumptions that could cause actual results or events to differ materially from
those expressed or implied by the forward-looking statements. These risks,
uncertainties and assumptions could adversely affect the outcome and financial
effects of the plans and events described herein. A multitude of factors
including, but not limited to, changes in demand, competition and technology,
can cause actual events, performance or results to differ significantly from any
anticipated development. Forward looking statements contained in this press
release regarding past trends or activities should not be taken as a
representation that such trends or activities will continue in the future. As a
result, the Company expressly disclaims any obligation or undertaking to release
any update or revisions to any forward-looking statements in this press release
as a result of any change in expectations or any change in events, conditions,
assumptions or circumstances on which these forward-looking statements are
based. Neither the Company nor its advisers or representatives nor any of its or
their parent or subsidiary undertakings or any such person’s officers or
employees guarantees that the assumptions underlying such forward-looking
statements are free from errors nor does either accept any responsibility for
the future accuracy of the forward-looking statements contained in this press
release or the actual occurrence of the forecasted developments. You should not
place undue reliance on forward-looking statements, which speak only as of the
date of this press release.
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