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ThromboGenics and BioInvent Receive Approval to Begin Clinical Trials for Anticoagulant TB-402

14 Feb 2007 - ThromboGenics NV and BioInvent International AB announced that they have received approval from the Danish Medicines Agency to initiate a Phase I clinical trial of the novel anticoagulant, TB-402. TB-402 is a human antibody binding to Factor VIII, which plays a crucial role in the coagulation of the blood. The project is being developed within the framework of the alliance between ThromboGenics and BioInvent.
 
The study is a randomised, placebo-controlled, dose escalation trial in healthy volunteers, and the objective is to investigate safety, tolerability and pharmacokinetic properties of the candidate drug. It is expected that the first subjects will be recruited in the study soon, and that the results will be presented in late 2007. Given a positive outcome of the initial Phase I study, the parties plan to follow up with a Phase IIa programme in patients undergoing orthopaedic surgery who are at risk for thrombosis. TB-402 is also expected to be developed as a potential treatment to prevent blood clot formation in connection with certain types of heart arrhythmia, such as atrial fibrillation.
 
TB-402 is a human antibody binding to Factor VIII, which plays a crucial role in the coagulation of the blood. The antibody has shown a beneficial partial inhibition of Factor VIII, even when applied in excess dosage. According to the companies, extensive testing in several animal models has shown that TB-402 strongly reduces the risk of thrombosis without increasing the risk of bleeding.