ThromboGenics NV and co-development partner BioInvent International announce today that the positive TB-402 (Anti-Factor VIII) Phase II trial results, evaluating the product's efficacy and safety for the prevention of venous thromboembolism (VTE) afterorthopaedic surgery, have been published in the Journal of Thrombosis and Haemostasis.
A paper entitled "Single Intravenous Administration of TB-402 for the Prophylaxis of Venous Thromboembolism after Total Knee Replacement: A Dose-Escalating, Randomised, Controlled Trial" has been published online ahead of print in JTH. This publication covers a recently completed dose finding Phase II trial with TB-402, with the objective of evaluating the efficacy and safety of three dose levels of single intravenous injection of TB-402 for preventing VTE after total knee surgery. The trial compared TB-402 withenoxaparin (Lovenox, sanofi-aventis), the standard treatment to prevent VTE in this setting.
The study showed that TB-402 was associated with a lower rate of VTE compared with enoxaparin. Pooled results of the TB-402 groups (0.3 mg/kg, 0.6 mg/kg and 1.2 mg/kg) showed a 22% incidence of total VTE compared with 39% for enoxaparin. In addition, TB-402 was generally well tolerated and demonstrated comparable safety to enoxaparin.
The results outlined in the articlehighlight thata single dose of TB-402 has the potential to improve preventive treatment of VTE after orthopaedic surgery by providing a stable, long-acting antithrombotic effect. The single dose administration may overcome poor patient compliance to therapy, one of the main causes of VTE in the real world. Furthermore, TB-402's novel mode of action could overcome thefrequent monitoring and dose adjustment requirements associated with many current anticoagulant treatments.
For a full discussion of the results, please refer to the JTH article. Further information is also included in the ThromboGenics press release dated 9 July, 2010 (see http://www.thrombogenics.com).
Professor Peter Verhamme, MD,of the University of Leuven, Belgium, and corresponding author of the JTHpaper,said, "We are delighted that these results with TB-402 have been published in a key academic journal. The trial data discussed in the paper demonstrate the potential benefits of TB-402 in improving treatments for the prevention of VTE after total knee surgery via a single dose. I very much look forward to the further development of TB-402 in this setting."