BioInvent and ThromboGenics Receive Approval to Begin Clinical Trials for Anticoagulant TB-402
- Category: Antibodies
- Published on Tuesday, 13 February 2007 02:00
- Hits: 2511
LUND, Sweden and LEUVEN, Belgium | Feb 12, 2007 | BioInvent International AB (OMXS:BINV) and ThromboGenics NV (Euronext Brussels: THR) announced today that they have received approval from the Danish Medicines Agency to initiate a Phase I clinical trial of the novel anticoagulant, TB-402. TB-402 is a human antibody binding to Factor VIII, which plays a crucial role in the coagulation of the blood. The project is being developed within the framework of the alliance between ThromboGenics and BioInvent.
The study is a randomised, placebo-controlled, dose escalation trial in healthy volunteers, and the objective is to investigate safety, tolerability and pharmacokinetic properties of the candidate drug. It is expected that the first subjects will be recruited in the study soon, and that the 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 programme in patients undergoing orthopaedic surgery who are at risk for thrombosis. TB-402 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.
Professor Désiré Collen, CEO and Chairman of ThromboGenics, commented: "The entry of TB-402 into formal clinical development is an important milestone for ThromboGenics and our partner BioInvent. We are both excited about the potential of this novel anti-coagulant, which acts via binding to Factor VIII, to prevent thrombosis in a number important disease settings."
"We are very pleased with the progress of this collaboration with ThromboGenics which has now reached the point when the first product is entering clinical trials." added Svein Mathisen, CEO of BioInvent.
TB-402 is a human antibody binding to Factor VIII, which plays a crucial role in the coagulation of the blood. The antibody has shown a beneficial partial inhibition of Factor VIII, even when applied in excess dosage. Extensive testing in several animal models has shown that TB-402 strongly reduces the risk of thrombosis without increasing the risk of bleeding.
The collaboration for development of TB-402 is carried out within the existing alliance between BioInvent and ThromboGenics, originally initiated in September 2004. Another joint programme focuses on the development of TB-403 (anti-PlGF) as a novel anti-angiogenesis therapy for treatment of tumours, inflammation and eye disease. In December 2006, ThromboGenics and BioInvent were awarded a Euro 2 Million EU Grant to support this programme.
SOURCE: BioInvent International AB