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New anti-clotting antibody enters trials

Published on 12/02/07 at 11:40am

European biotech companies ThromboGenics and BioInvent are to start a phase I trial of a new drug which could prove to be a safer and more convenient anti-clotting treatment.

Patients taking anti-coagulants today have to be monitored closely to ensure the drugs do not cause bleeding, but early data suggests the new TB-402 is free of this concern.

The study will investigate the safety, tolerability and pharmacokinetic properties of the drug, with results expected in late 2007.

TB-402 is a human antibody binding to Factor VIII, which plays a crucial role in the coagulation of the blood. Extensive testing in several animal models has shown that TB-402 strongly reduces the risk of thrombosis without increasing the risk of bleeding.

The companies were awarded a two million euro grant by the EU in December to fund the programme. TB-402 represent the first drug in a wider alliance between ThromboGenics and BioInvent to reach the clinical phase.

The companies hope to continue development into phase IIa trials in patients undergoing orthopaedic surgery who are at risk for thrombosis. TB-402 is also expected to be developed as a treatment to prevent blood clots in patients with certain types of heart arrhythmia, such as atrial fibrillation.

Professor Dsir Collen, chief executive of ThromboGenics commented: "The entry of TB-402 into formal clinical development is an important milestone for ThromboGenics and our partner BioInvent. We are both excited about the potential of this novel anti-coagulant, which acts via binding to Factor VIII, to prevent thrombosis in a number important disease settings."

The development of TB-402 is part of an alliance between ThromboGenics and BioInvent launched in September 2004. The companies are also working on the development of TB-403 (anti-PlGF), a novel anti-angiogenesis therapy for treatment of tumours, inflammation and eye disease.

ThromboGenics, based in Leuven in Belgium has five products already in phase II development, three in cardiovascular disease and two in ophthalmology.

The company's lead product is microplasmin, a stable proteolytic enzyme which is in phase II trials for eye disease and thrombotic disease.

BioInvent is based in Lund, Sweden and is collaborating with a number of other companies on developing new drugs, including ALK-Abell, Antisoma, GlaxoSmithKline and ImmunoGen.

In January, BioInvent struck another licensing deal which may prove to be one of its most important. Genentech, the company behind drugs such as Herceptin and Avastin, signed a deal with the company to develop and co-market a new cardiovascular drug.

BI-204 is in pre-clinical development, but could be the first drug to directly block the furring-up of arteries which eventually leads to heart attacks and strokes.

Genentech has made an upfront payment of $15 million to BioInvent with up to $175 million in milestones and further royalties on sales in North America also due if and when the drug reaches the market.  The two companies co-develop the drug, with Genentech marketing the drug in North America, and BioInvent holding marketing rights in the rest of the world.

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