Recruitment of Phase II trial of TB-402 completed ahead of schedule

Oct 28 2009

Recruitment of 315 Patients Completed Ahead of Schedule - Results Anticipated in the second quarter of 2010

ThromboGenics NV (Euronext Brussels: THR) and co-development partner BioInvent International (OMXS: BINV) announce that they have completed recruitment of their Phase II trial of TB-402 ahead of schedule. TB-402 is a novel, long acting anticoagulant that is being developed for the prevention of deep vein thrombosis (DVT) following orthopaedic surgery. The results of this study, which has recruited 315 patients, are anticipated in the second quarter of 2010.

TB-402 has the potential to be a very important new entrant into the anticoagulant market. TB-402 is a recombinant human monoclonal antibody that partially inhibits Factor VIII, a key component of the coagulation cascade. This novel mode of action is expected to reduce the risk of undesirable bleeding events, even at high doses, as well as the need for patient monitoring. These are the two main drawbacks associated with current anticoagulant therapy. In addition, TB-402 is a long-acting agent, which means it could be given as a single dose to prevent the development of DVT in patients undergoing surgery. This would be an attractive option, as all current anticoagulant treatment options require daily treatment for up to several weeks.

The Phase II trial is an active (enoxaparin)-controlled, dose-escalating, multicenter, prospective, randomised, open label trial evaluating TB-402 for the prophylaxis of DVT after knee surgery. The study is assessing three different doses of TB-402 (0.3, 0.6 and 1.2 mg/kg) each given as a single intravenous bolus injection post knee replacement surgery. The objective of the study is to assess the safety and efficacy of the three escalating doses of TB-402. The study enrolled a total of 315 patients across 30 centers, mainly in Europe.

Patrik De Haes, CEO of ThromboGenics, commented, "We are very pleased to announce the completion of enrolment ahead of schedule for TB-402. We believe that based on its novel profile, TB-402 could be an important new entrant into the anticoagulant therapy market. Given the size of commercial opportunity for TB-402 and the sales reach that will be needed to engage with all of the potential prescribers of TB-402, it is our intention to seek a partner to undertake the later stage development and commercialisation of this exciting new agent. We very much look forward to announcing the results from this study in Q2 next year."

Svein Mathisen, CEO of BioInvent, also commented, "At BioInvent, we are proud to have maintained excellent momentum in the Phase II study of TB-402, which is on track to be completed ahead of schedule. We look forward to announcing the results of the study in Q2 next year. Our expectation is that the ongoing clinical development will underpin the product profile as a safe and effective long acting new anticoagulant."