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Biotech / Medical : HuMAB companies -- Ignore unavailable to you. Want to Upgrade?

To: nigel bates who wrote (942)	9/9/2009 6:20:57 AM
From: nigel bates	Read Replies (1) \| Respond to of 1022

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.