Ablynx Reports Detailed Positive Phase Ib Results for Its Anti- Thrombotic Nanobody(R) ALX-0081
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GHENT, BELGIUM, Mar 30 (MARKET WIRE) --
Ablynx [Euronext Brussels: ABLX], a pioneer in the discovery and
development of Nanobodies(R), a novel class of antibody-derived
therapeutic proteins, announced today the detailed results from the Phase
Ib study of its anti- thrombotic ALX-0081. The primary endpoint,
demonstrating the complete inhibition of the target protein as measured
by a specific biomarker, was reached in December 2008. These positive
detailed data support the progression of ALX-0081 into Phase II testing,
expected to commence in Q3 2009.
During the period May to December 2008, the study recruited a total of 25
patients with stable angina undergoing an elective percutaneous coronary
intervention (PCI) procedure. Total daily doses of ALX- 0081 ranging from
2 to 18 mg were added to a standard anti- thrombotic regimen including
aspirin, heparin and Plavix(R). The double blind study randomized
patients in a 3:1 ratio to either active study drug (ALX-0081) or
placebo, resulting in a total of 19 patients receiving ALX-0081
intravenous infusions and six patients receiving placebo. The biological
effect of ALX-0081 was determined via a biomarker, indicating the
complete inhibition of von Willebrand Factor (vWF) and its mediated
effect on platelet aggregation and clotting in coronary arteries.
The study included a single dose and a multiple dose escalation. Single
doses were escalated until the required biological effect (complete
biomarker inhibition for at least six hours in all ALX- 0081 treated
patients) was confirmed. The subsequent multiple dosing was aimed to
ensure complete inhibition of the biomarker for at least 24 hours. All
patients who received ALX-0081 showed complete inhibition of the
biomarker with a duration of 4 to 18 hours in the single dose group and
for at least 24 hours in the multiple dose group. In all patients, the
pharmacological markers returned to normal 12-36 hours after dosing.
This announcement was originally distributed by Hugin. The issuer is
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Copyright Hugin AS 2009. All rights reserved.
For more information, please contact:
College Hill Life Sciences - for UK/International media enquiries:
Sue Charles, Justine Lamond, Dr John McIntyre
t: +44 (0)20 7866 7857
e: Email 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: Email Contact
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: Email Contact
Copyright 2009, Market Wire, All rights reserved.
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