TRIGEN COMPLETES PHASE II STUDY OF TGN 255
Trigen announced the preliminary results of its Phase II study of anticoagulation in hemodialysis for its novel intravenous anticoagulant, TGN 255.
The results are presented in a presentation entitled "Effect of TGN 255, a Novel Intravenous Direct Thrombin Inhibitor, on the Prolongation of ACT in Patients Undergoing Hemodialysis," which was given at the International Society on Thrombosis and Hemostasis in Sydney, Australia.
Trigen conducted the study in 28 patients undergoing hemodialysis at several sites in Europe to assess whether TGN 255 would adequately anticoagulate the extra corporeal circuit in hemodialysis in patients with end-stage renal failure and to evaluate the pharmacokinetics and pharmacodynamics of the drug in this setting. Each patient underwent at least three dialysis sessions with TGN 255 following a baseline session with unfractionated heparin. The results suggest that TGN 255 provided effective and convenient anticoagulant cover in this setting with a high level of control and with no increase in bleeding risk. Final results are expected later in the year, the company said.