BioInvent International has started recruitment of the third and final cohort of 100 patients for the Phase II trial of TB-402, a drug being developed for the prevention of deep vein thrombosis
Lund, Sweden | September 23, 2009 | BioInvent International AB (OMXS) announces that it has started recruitment of the third and final cohort of 100 patients for the Phase II trial of TB-402, a drug being developed for the prevention of deep vein thrombosis. The first two patient cohorts included in total 200 individuals and the recruitment for the second cohort was concluded in August. The decision to start recruitment of the third patient cohort follows an unanimous recommendation from the external board monitoring the efficacy and safety of the study.
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 injection post knee replacement surgery and the trial will enrol 300 patients. The objective of the study is to assess the safety and efficacy of the three escalating doses of TB-402. All the patients in the study will be monitored for a period of three months after surgery. TB-402 is developed in collaboration with ThromboGenics NV.
Svein Mathisen, CEO of BioInvent, commented, “We are very pleased with the fast progress of our TB-402 trial and expect that all 300 patients will be included in the trial by the end of the year. After follow up and compiling the data, we expect to be able to report the results by mid 2010. This is six months ahead of the original schedule.”
About TB-402
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 anticoagulants. In addition, TB-402 is a long-acting agent, which means it could be given as a single dose after surgery to prevent the development of DVT. This would be an attractive option, as all current anticoagulant treatment options require daily treatment for up to several weeks.
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.
[1] ‘The Surgeon General’s Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism’, September 15, 2008, p.1.
[2] “Changes in Surgical Loads and Economic Burden of Hip and Knee Replacements in the US: 1997-2004,” Sunny Kim, Arthritis & Rheumatism (Arthritis Care & Research), April 15, 2008; 59:4, pp. 481-488.
About BioInvent
BioInvent International AB, listed on the NASDAQ OMX Stockholm (BINV), is a research-based pharmaceutical company that focuses on developing antibody drugs. The Company is currently running innovative drug projects within the areas of thrombosis, cancer and atherosclerosis. The Company has signed various strategic alliances around these product candidates and is developing them in collaboration with partners including Genentech, Roche and ThromboGenics.
SOURCE: BioInvent International AB
Post Views: 62
BioInvent International has started recruitment of the third and final cohort of 100 patients for the Phase II trial of TB-402, a drug being developed for the prevention of deep vein thrombosis
Lund, Sweden | September 23, 2009 | BioInvent International AB (OMXS) announces that it has started recruitment of the third and final cohort of 100 patients for the Phase II trial of TB-402, a drug being developed for the prevention of deep vein thrombosis. The first two patient cohorts included in total 200 individuals and the recruitment for the second cohort was concluded in August. The decision to start recruitment of the third patient cohort follows an unanimous recommendation from the external board monitoring the efficacy and safety of the study.
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 injection post knee replacement surgery and the trial will enrol 300 patients. The objective of the study is to assess the safety and efficacy of the three escalating doses of TB-402. All the patients in the study will be monitored for a period of three months after surgery. TB-402 is developed in collaboration with ThromboGenics NV.
Svein Mathisen, CEO of BioInvent, commented, “We are very pleased with the fast progress of our TB-402 trial and expect that all 300 patients will be included in the trial by the end of the year. After follow up and compiling the data, we expect to be able to report the results by mid 2010. This is six months ahead of the original schedule.”
About TB-402
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 anticoagulants. In addition, TB-402 is a long-acting agent, which means it could be given as a single dose after surgery to prevent the development of DVT. This would be an attractive option, as all current anticoagulant treatment options require daily treatment for up to several weeks.
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.
[1] ‘The Surgeon General’s Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism’, September 15, 2008, p.1.
[2] “Changes in Surgical Loads and Economic Burden of Hip and Knee Replacements in the US: 1997-2004,” Sunny Kim, Arthritis & Rheumatism (Arthritis Care & Research), April 15, 2008; 59:4, pp. 481-488.
About BioInvent
BioInvent International AB, listed on the NASDAQ OMX Stockholm (BINV), is a research-based pharmaceutical company that focuses on developing antibody drugs. The Company is currently running innovative drug projects within the areas of thrombosis, cancer and atherosclerosis. The Company has signed various strategic alliances around these product candidates and is developing them in collaboration with partners including Genentech, Roche and ThromboGenics.
SOURCE: BioInvent International AB
Post Views: 62
