Thrombogenics/BioInvent's TB-402 enters Ph I trial

Lund, Sweden-based BioInvent International and Belgian drugmaker ThromboGenics NV has received approval from the Danish Medicines Agency to initiate a Phase I clinical trial of the novel anticoagulant, TB-402, a human antibody binding to Factor VIII, which plays a crucial role in the coagulation of the blood.

The study, which is being developed within the framework of the alliance between ThromboGenics and BioInvent is a randomized, placebo-controlled, dose-escalation trial in healthy volunteers, and the objective is to investigate safety, tolerability and pharmacokinetic properties of the candidate drug.

The firms expect that the first subjects will be recruited into the study soon, and that 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 program in patients undergoing orthopedic surgery who are at risk for thrombosis. The drug 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.