ABLYNX INITIATES PHASE II CLINICAL TRIAL FOR ALX-0081
(Thomson Reuters ONE) - GHENT, Belgium, 1 September 2009 - Ablynx [Euronext Brussels: ABLX]today announced the initiation of a Phase II study for itsanti-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 thesafety and efficacy of multiple doses of ALX-0081 versus theGPIIb/IIIa inhibitor ReoPro® in patients undergoing percutaneouscoronary intervention (PCI). Patients with unstable angina orpatients with stable angina with at least two factors indicating highrisk will be included in this study. ALX-0081 or ReoPro® will beadded to a standard anti-thrombotic regimen including aspirin,heparin and Plavix®. This multi-institutional, pan-European Phase IIstudy is planned to enroll close to 370 patients.Ablynx recently concluded a successful ALX-0081 Phase Ib study inpatients with stable angina undergoing a planned PCI procedure. Thedrug's biological effect was determined using a biomarker, indicatingthe complete inhibition of vWF and its mediated effect on plateletaggregation and clotting in coronary arteries. ALX-0081 showed anexcellent efficacy and safety profile in this patient study. In orderto gain additional information on optimal dosing and scheduling,Ablynx has extended this Phase Ib study to look in more detail atbiological markers, optimization of concurrent treatment with thestandard anti-thrombotic regimen, tolerance and administration. Datafrom this Phase Ib study extension will be reported in a few months."Initiation of Phase II clinical development of ALX-0081 is a majormilestone for Ablynx," commented Edwin Moses, CEO and Chairman. "Thisstudy builds on our recent rapid progress and success, generatingencouraging safety and efficacy data in patients. ALX-0081 has thepotential to become a safe, first-in-class anti-platelet agent. Weare delighted that the first patient in this important study wastreated in Aalst, Belgium."For more information, please contact:For international media enquiries:College Hill Life SciencesSue Charles,Justine Lamond,Dr. John McIntyret: +44 (0)20 7866 7857e: ablynx(at)collegehill.comAblynx:Dr. Edwin MosesChairman and CEOt: +32 (0)9 262 00 07m: +44 (0)7771 954 193 / +32 (0)473 39 50 68e: edwin.moses(at)ablynx.comEva-Lotta AllanChief Business Officert: +32 (0)9 262 00 75m: +32 (0)475 78 36 21 / +44 (0)7990 570 900e: eva-lotta.allan(at)ablynx.comhttp://hugin.info/137912/R/1338761/319541.pdfThis announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 01.09.2009 - 18:00 Uhr
Sprache: Deutsch
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