Ph II trial of TB-402 starts enrolling

Belgium's ThromboGenics NV and Sweden's BioInvent says that the first patient has been enrolled in a Phase II trial of their long-acting  anticoagulant TB-402 for the prophylaxis of deep vein thrombosis  following orthopedic surgery.

The recombinant human monoclonal antibody targets Factor VIII, a key  component of the coagulation cascade. According to the firms, the  product could overcome the major drawbacks such as bleeding and the need  for extensive patient monitoring associated with current anti-coagulant  therapy.

The Phase II trial is an enoxaparin-controlled, dose-escalating,  multicenter, prospective, randomized, open-label evaluation of TB-402  for the prophylaxis of DVT after knee surgery. The study will assess  three different doses of TB-402 given as a single intravenous bolus  injection post knee-replacement surgery. The trial will enrol 300  patients across 36 centers mainly in central Europe. The primary  endpoint is the safety and efficacy of the three escalating doses of  TB-402. It is anticipated that the study will conclude by the end of  2010.