ThromboGenics Presents Results of the Phase I Trial of TB-402 at the Prestigious American Society of Hematology Annu... (confirms aprolonged half-life of approxi...)

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ThromboGenics Presents Results of the Phase I Trial of TB-402 at the Prestigious American Society of Hematology Annual Meeting

Date:12/11/2007

confirms a prolonged half-life of approximately three weeks, which will allow for single-dose treatment in orthopaedic surgery patients and/or a once-a-month administration for long-term stroke prevention in atrial fibrillation (AF). The pharmacodynamic analysis also shows stable and long-acting anticoagulant activity. The Joint Steering Committee of ThromboGenics and BioInvent confirm their previous decision to move TB-402 into Phase II clinical development. As part of the development program, drug interaction studies will be performed in H1 2008 in parallel with the preparatory work needed to start the Phase II trial. The initial Phase II trial will be a dose-ranging clinical trial evaluating safety and efficacy (to prevent deep vein thrombosis, or DVT) in an orthopaedic surgery setting.

Professor Peter Verhamme, Department of Vascular Diseases, University of Leuven, who presented the results at the ASH meeting, commented: "The results from the first Phase I study with TB-402 show that this novel human monoclonal antibody is safe and well-tolerated, an important first step in the development of this new anticoagulant drug. Of equal importance, the results clearly indicate that TB-402 has the long half-life we predicted and a stable long-acting anticoagulant effect based on partial factor VIII inhibition. We are looking forward to starting the Phase II clinical trials, which will investigate the potential of TB-402 in the prevention of thromboembolic disorders."

Thromboembolic Disease

Thromboembolic diseases represent a major unmet medical need. The annual sales of anticoagulants (drugs that prevent blood clots) worldwide are over $5 billion. Nevertheless, available anticoagulants are still inconvenient and associated with a high risk of bleeding. Improved anticoagulants are therefore required. In particular, agents that allow for improved ease of administration (without requirement for daily dosing and frequent dose adjustment) would fill a s
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ThromboGenics Presents Results of the Phase I Trial of TB-402 at the Prestigious American Society of Hematology Annu...(confirms aprolonged half-life of approxi...)