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. The primary efficacy outcome of the study was the incidence of total VTE up to 35 days post operatively. VTE consisted of both asymptomatic deep vein thrombosis (DVT), as detected by bilateral venography, and symptomatic VTE, i.e. DVT or pulmonary embolism (PE). The principle safety outcome was major bleeding or clinically relevant non-major bleeding events up to 35 days after surgery. The study showed that the incidence of VTE was similar for TB-402 and rivaroxaban. In the pooled TB-402 group, 5.3% of patients had VTE, compared with 4.7% in the group treated with rivaroxaban. All incidences were asymptomatic DVT. However, major or clinically relevant non-major bleeding occurred in 6.5% of the patients treated with TB-402 compared to 1.4% of patients treated with rivaroxaban, a statistically significant difference.
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV