GHENT, BELGIUM--(Marketwire - June 29, 2011) -
GHENT, Belgium, 29 June 2011 - Ablynx [Euronext Brussels: ABLX] today
announced
that it has initiated a Phase I clinical trial in healthy volunteers with
ALX-
0651, an anti-CXCR4 Nanobody, for use in stem cell mobilisation. ALX-0651
is the
first Nanobody in clinical trials targeting a GPCR, a target class
that has
proven to be difficult to address with conventional antibodies. It is the
second
Nanobody that has entered clinical development this year, which brings the
total
number of Nanobodies in the clinic to seven.
CXCR4 plays a key regulatory role in hematopoietic stem cell
trafficking.
Blocking CXCR4 effectively releases the hematopoietic stem cells from the
bone
marrow and allows them to be mobilised to the peripheral blood for
collection
and subsequent transplantation in patients.
Hematopoietic stem cell transplantation is used to reconstitute the bone
marrow
and repopulate the blood and immune system in patients whose immune
system has
been depleted of stem cells as a result of high-dose chemotherapy. It has
become
a widely used procedure in patients with multiple myeloma and non-
Hodgkin's
lymphoma.
The Phase I study will evaluate the safety and tolerability of ALX-
0651. The
study will investigate the PK/PD and immunogenicity profile of the
Nanobody and
will establish one or more biologically effective dose levels and/or the
maximum
tolerated dose.
The study is expected to recruit between 70 and 120 healthy volunteers and
will
include a single-blinded, placebo-controlled single ascending dose phase
with
six to seven dose levels, followed either by an open-label extension phase
or a
multiple dose phase.
Dr Edwin Moses, CEO and Chairman of Ablynx, commented: "We are delighted
to see
our first Nanobody that targets a GPCR progressing into the clinic. GPCRs
form
part of an important drug target class that is difficult to address
with
conventional antibodies but the unique characteristics of our Nanobodies
have
allowed us to generate active lead Nanobody candidates for a number of
different
GPCRs. We are looking forward to seeing the outcome of this first clinical
study
during the course of 2012. There are now seven Nanobodies in
clinical
development and we are on track internally to initiate a third Phase I
study
this year before the end of 2011."
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
Marieke Vermeersch
Investor Relations Manager
t: +32 (0)9 262 00 82
m: +32 (0)479 49 06 03
e: marieke.vermeersch@ablynx.com
Complete version of the press release:
http://hugin.info/137912/R/1527019/462724.pdf
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originality of the information contained therein.
Source: Ablynx via Thomson Reuters ONE
[HUG#1527019]
