ABLYNX ANNOUNCES POSITIVE PHASE I RESULTS FOR SUBCUTANEOUS
ADMINISTRATION OF ITS ANTI-THROMBOTIC NAN
(Thomson Reuters ONE) - GHENT, Belgium, 18 August 2009 - Ablynx [Euronext Brussels: ABLX]today announced the positive results from its double-blind,randomized, placebo-controlled, single and multiple dose Phase Istudy with ALX-0681, a subcutaneous formulation of its novelanti-thrombotic Nanobody® that selectively targets von Willebrandfactor (vWF). The positive Phase I data support the progression ofALX-0681 towards Phase II testing in patients with thromboticthrombocytopenic purpura (TTP), expected to commence in Q2 2010. Theanti-vWF Nanobody® received orphan drug designation by the EMEA andthe FDA for the treatment of TTP in May this year.The Phase I study was designed to investigate the safety,tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) ofsingle and repeated subcutaneous administrations of ALX-0681. A totalof 36 healthy volunteers were treated with either single subcutaneousdoses of ALX-0681 ranging from 2mg to 16mg or daily 10 mgsubcutaneous injections for 7 or 14 days.All administrations of ALX-0681 were well tolerated and did notresult in clinically significant adverse events. No signs of localintolerance or clinically significant bleeding events occurred and noevidence of immunogenicity was observed for 45 days after completionof treatment.The desired biological effect, determined by complete inhibition of abiomarker, was achieved for more than 14 days with daily injectionsof 10mg of the anti-vWF Nanobody® confirming the biological efficacyof ALX-0681. The PD parameters for coagulation Factor VIII and vWFshowed a fast and reversible decrease compared to pre-dose values,with normalisation between 24 and 72 hours after the lastadministration, depending on dose. The PK profile remained unchangedafter multiple administrations, confirming the favourablepharmacological behaviour of ALX-0681.ALX-0681 is being developed for the treatment of patients with TTP.It is also anticipated that the subcutaneous administration ofALX-0681 will provide access to additional patient populationssuffering from unwanted blood-clot formation, such as those withacute coronary syndrome (ACS), which are not currently addressed bythe intravenous administration of ALX-0081.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/1335615/317457.pdfThis announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 18.08.2009 - 18:00 Uhr
Sprache: Deutsch
News-ID 4838
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