Lund, Sweden and Leuven, Belgium – 23 February 2009 - BioInvent International AB (OMXS:BINV) and ThromboGenics NV (EURONEXT:THR) announce today that the first patient has been enrolled into the Phase II trial with their long-acting anticoagulant TB-402 for the prophylaxis of Deep Vein Thrombosis (DVT) following orthopaedic surgery. TB-402, which is given as a single injection post surgery, could overcome the major drawbacks such as bleeding and the need for extensive patient monitoring associated with current anti-coagulant therapy.
TB-402 is a recombinant human monoclonal antibody that targets Factor VIII, a key component of the coagulation cascade. TB-402 is a novel anticoagulant agent, which may deliver important clinical benefits due to it only partially inhibiting Factor VIII activity even when given in very high doses. This novel mode of action is expected to reduce the risk of undesirable bleeding events and the need for patient monitoring, the two main drawbacks associated with current anticoagulants. In addition, TB-402 is a long-acting agent which means that patients are expected to receive just one single dose after surgery to prevent the development of DVT, as opposed to all current treatment options which 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 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.
Svein Mathisen, CEO of BioInvent, commented on today’s news “The initiation of this Phase II trial is another successful step forward in the clinical development of our antibody product development portfolio. TB-402 addresses a broad market and has potentially significant advantages over existing anti-coagulants. We are hopeful it will have application in a number of clinical settings.”
Patrik De Haes, CEO of ThromboGenics, also commented “We are very excited about the start of the Phase II trial for TB-402. Our work to date suggests that this novel agent could represent a major advance in anti-coagulant therapy, given our expectation that it will cause fewer unwanted bleeding events and will require no monitoring of patients. This combined with its ability to be used as a “one-off” treatment could make TB-402 the anti-coagulant of choice to prevent DVT in patients undergoing surgery. Given the size of the market opportunity for TB-402 and the sales reach that will be needed to engage with 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.”
About Deep Vein Thrombosis (DVT)
DVT is caused when a blood clot forms in a deep vein, most commonly in the deep veins of the lower leg. DVT is a major public health issue and it is estimated that in the US alone, more than 350,000 individuals are affected by DVT or pulmonary embolism (PE) each year. Moreover, DVT and PE together may be responsible for more than 100,000 deaths in the U.S. each year. [1]
It is estimated that by 2015, 1.4 million patients will undergo knee replacement and 600,000 patients will undergo hip replacement in the U.S. if current trends persist. [2] Patients undergoing hip replacement or knee surgery are particularly at risk of developing DVT and all patients are therefore treated with anticoagulants prophylactically in order to reduce the risks of blood clots. The annual sales of anticoagulants worldwide are over $5 billion. Nevertheless, available anticoagulants are still inconvenient and associated with an increased 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 significant unmet need.
