August 15, 2005

Bayer HealthCare has presented safety and efficacy results from two large randomized Phase II studies for a novel, oral, direct Factor Xa inhibitor (BAY 59-7939) for prevention of venous thromboembolism (VTE). The data were presented at the 20th Congress of the International Society on Thrombosis & Hemostasis in Sydney, Australia.

The two prospective dose-finding studies included more than 1,300 patients and demonstrated safety and efficacy for BAY 59-7939 similar to enoxaparin, a low molecular weight heparin, in preventing the incidence of venous thromboembolism in patients undergoing either knee or hip replacement surgery. In contrast to the current gold standard enoxaparin, which must be given subcutaneously, BAY 59-7939 has the advantage that it can be administered orally. In both studies, BAY 59-7939 was given twice daily in tablet form. At the moment, additional studies are investigating the efficacy and safety of administering BAY 59-7939 to patients once a day.

Safety and efficacy of BAY 59-7939 was shown across a wide dose range of 2.5-10 mg given twice daily in the studies. BAY 59-7939 achieved the endpoints of both studies, which aimed to evaluate optimal dosing for future clinical studies. In terms of postoperative bleeding frequency, there were no differences between the subcutaneously injected enoxaparin and the orally administered BAY 59-7939 over this dose range.