Ablynx announced today that it has initiated a double-blind, randomized, placebo-controlled Phase I study in healthy volunteers with ALX-0681
GHENT, Belgium | December 8, 2008 | Ablynx [Euronext Brussels: ABLX], a pioneer in the discovery and development of Nanobodies®, a novel class of antibody-derived therapeutic proteins, announced today that it has initiated a double-blind, randomized, placebo-controlled Phase I study in healthy volunteers with ALX-0681. The subjects will receive a subcutaneous injection of the novel anti- thrombotic Nanobody® that selectively targets von Willebrand (vWF) factor.
The Phase I study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeated subcutaneous administrations of ALX-0681. Ablynx will recruit up to 36 healthy volunteers for this study.
It is anticipated that subcutaneous administration of ALX-0681 will provide access to additional patient populations suffering from unwanted blood-clot formation, such as acute coronary syndrome (ACS), that are not currently addressed by the intravenous administration of ALX-0081. In addition, ALX-0681 is also being developed for the treatment of patients with thrombotic thrombocytopenic purpura (TTP).
"Ablynx is committed to developing its own internal pipeline of Nanobody®-based drugs and, with the positive progress to date of our lead product, ALX-0081, which also selectively targets von Willebrand factor, we are delighted to have now advanced a second product from our platform, ALX-0681, into a healthy volunteer Phase I study," commented Dr Edwin Moses, Chairman and Chief Executive Officer.
About ALX-0681 and ALX-0081
ALX-0681 and ALX-0081 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-0681, a new potential anti-thrombotic agent, 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.
SOURCE: Ablynx
Post Views: 151
Ablynx announced today that it has initiated a double-blind, randomized, placebo-controlled Phase I study in healthy volunteers with ALX-0681
GHENT, Belgium | December 8, 2008 | Ablynx [Euronext Brussels: ABLX], a pioneer in the discovery and development of Nanobodies®, a novel class of antibody-derived therapeutic proteins, announced today that it has initiated a double-blind, randomized, placebo-controlled Phase I study in healthy volunteers with ALX-0681. The subjects will receive a subcutaneous injection of the novel anti- thrombotic Nanobody® that selectively targets von Willebrand (vWF) factor.
The Phase I study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeated subcutaneous administrations of ALX-0681. Ablynx will recruit up to 36 healthy volunteers for this study.
It is anticipated that subcutaneous administration of ALX-0681 will provide access to additional patient populations suffering from unwanted blood-clot formation, such as acute coronary syndrome (ACS), that are not currently addressed by the intravenous administration of ALX-0081. In addition, ALX-0681 is also being developed for the treatment of patients with thrombotic thrombocytopenic purpura (TTP).
"Ablynx is committed to developing its own internal pipeline of Nanobody®-based drugs and, with the positive progress to date of our lead product, ALX-0081, which also selectively targets von Willebrand factor, we are delighted to have now advanced a second product from our platform, ALX-0681, into a healthy volunteer Phase I study," commented Dr Edwin Moses, Chairman and Chief Executive Officer.
About ALX-0681 and ALX-0081
ALX-0681 and ALX-0081 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-0681, a new potential anti-thrombotic agent, 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.
SOURCE: Ablynx
Post Views: 151
