ThromboGenics and BioInvent Announce Results from Phase IIb Venous Thromboembolism Prevention Study with TB-402

ThromboGenics and BioInvent Announce Results from Phase IIb Venous Thromboembolism Prevention Study with TB- 402 PR Newswire LEUVEN, Belgium and LUND, Sweden, June 5, 2012 LEUVEN, Belgium and LUND, Sweden, June 5, 2012 /PRNewswire/ -- - All further development of TB-402 will be stopped ThromboGenics NV (Euronext Brussels: THR) and co-development partner BioInvent International (OMXS: BINV) announce today the results from a Phase IIb trial comparing TB-402, a long acting anticoagulant, against rivaroxaban (Xarelto®; Bayer), an oral anticoagulant. The study showed that the incidence of venous thromboembolism (VTE) was similar with both drugs, but patients receiving TB-402 had a significantly higher incidence of bleeding events. Based on these results, ThromboGenics and BioInvent have decided to stop further development of TB-402. The Phase IIb trial was a multicenter, randomised, double blind trial, evaluating single doses of either 25 or 50 mg TB-402 against rivaroxaban in patients undergoing hip replacement surgery. Rivaroxaban is a recently approved oral factor Xa inhibitor for the prevention of VTE after elective hip or knee replacement surgery. TB-402 was administered as a single intravenous infusion two to four hours post-operatively, and rivaroxaban was administered as 10 mg once daily for 35 days. A total of 632 patients were enrolled between April and December 2011 in 36 centers across nine countries.