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Positive data from two large randomized Phase IIb trials for a novel, oral, direct Factor Xa inhibitor (BAY 59-7939) for the prevention of venous thromboembolism (VTE)
have been published today by the "International Society for Thrombosis and Haemostasis (ISTH)". The news has been posted on the www.isth2005.com1 website in advance of the ISTH's annual meeting to be held on August 6-12, 2005 in Sydney.
The Phase-IIb dose-finding studies included 1,327 patients undergoing either elective total knee or hip replacement surgery. The studies demonstrated that oral BAY 59-7939, given twice daily, was safe and effective across a wide dose range of 2.5-10 mg in lowering the incidence of venous thromboembolism. The two clinical trials were performed to assess the efficacy and safety of oral BAY 59-7939 relative to the current gold standard enoxaparin, a low molecular weight heparin given subcutaneously, for the prophylaxis of venous thromboembolism.
"BAY 59-7939 has the potential to add significantly to the options available for prevention and treatment of thromboembolism. This is an area where patients have a strong need for alternative treatments, that are easy to administer and do not require monitoring. At present, there are no oral direct Factor Xa inhibitors available commercially," said Wolfgang Plischke, President of Bayer HealthCare�s Pharmaceuticals Division.
In the knee replacement study observed rates of VTE were lower for all doses of BAY 59-7939 compared with the gold standard enoxaparin. In addition, there were no differences in terms of major post-operative bleeding events for oral BAY 59-7939 in doses ranging from 2.5, 5 and 10 mg twice daily compared with subcutaneous enoxaparin.
In the hip replacement study incidence of VTE in patients receiving oral Bay 59-7939 twice daily, in a wide dose range of 2.5-10 mg, was similar to patients given enoxaparin 40 mg subcutaneously. There were also no significant differences in the rates of bleeding between individual BAY 59-7939 doses and enoxaparin. Data from both studies indicate that BAY 59-7939 was well tolerated and did not reveal any unexpected safety problems. Serious adverse effects in the 2.5-10 mg dose range were rare and occurred at a comparable level with enoxaparin. All current clinical data suggests that liver monitoring will not be necessary.
The clinical findings from these two studies strongly support that oral BAY 59-7939 be successfully moved from phase II to phase III.
The full results of these dose-ranging studies will be presented by the principle investigators of the two studies on August 8, 2005, at the conference of the ISTH in Sydney, Australia.
About BAY 59-7939
BAY 59-7939, is an oral, direct Factor Xa inhibitor being developed by Bayer HealthCare. It is currently in phase II clinical trials. The novel compound plays a central role in the blood coagulation cascade. BAY 59-7939 has been shown to inhibit free Factor Xa and prothrombinase activity. In this way, the direct Factor Xa inhibitor BAY 59-7939 prevents thrombin generation in the coagulation pathway.
About Venous Thromboembolism (VTE)
Deep vein thrombosis and pulmonary embolism represent different manifestations of the same clinical entity, and are referred to as venous thromboembolism (VTE). Venous thrombosis is a blood clot (thrombus) that remains in the place where it formed and interferes with blood circulation of the area. It occurs frequently in high-risk patients undergoing major orthopedic surgery.
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This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including our Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
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