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Trigen Announces the Successful Completion of a Phase II Study of TGN 255 for Anticoagulation in Haemodialysis

Posted on: Tuesday, 9 August 2005, 21:00 CDT

Preliminary results presented at XXth Congress of the International Society of Thrombosis and Haemostasis (ISTH), Sydney, Australia, August 6-12, 2005

MUNICH and LONDON, Aug. 9, 2005 (PRIMEZONE) -- Trigen Holdings AG today announced the preliminary results of its Phase II study of anticoagulation in haemodialysis for its novel intravenous anticoagulant, TGN 255, at the XXth Congress of the ISTH in Sydney, Australia. 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 Haemodialysis.'

Trigen conducted the study in 28 patients undergoing haemodialysis at several sites in Europe to assess whether TGN 255 would adequately anticoagulate the extra corporeal circuit in haemodialysis 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 during the autumn of 2005. However, these preliminary data support the progression of TGN 255 into late-stage clinical trials in this indication as planned.

Trigen is presenting a total of nine scientific presentations at ISTH, highlighting developments in its intravenous (TGN 255) and oral (TGN 167) small molecule Direct Thrombin Inhibitor (DTI) programmes. Full details are listed at the end of this press release.

TGN 255 is a novel intravenous small-molecule DTI being developed as a predictable and safer alternative for anticoagulation in hospital settings. Anticoagulation in haemodialysis is the lead indication for TGN 255. Trigen is also planning to develop TGN 255 in cardiovascular indications.

Trigen Holdings AG is a biotechnology company, with operations in London and Munich and is a leader in cardiovascular drug discovery and development, focussing on thrombosis and vascular dysfunction. The company's expanded product pipeline includes the existing clinical stage candidates, TGN 255 and TGN 167, and PR-15, which is expected to enter the clinic early in 2006. The company also has an extensive portfolio of exciting pre-clinical and discovery stage programmes targeting thrombosis, atherosclerosis and other cardiovascular pathologies. In addition, Trigen benefits from two established discovery platforms, SIGSCREEN(R) and THROMSCAN(R) which have been applied in collaborations with a number of multinational pharmaceutical companies.

Trigen scientific presentations at ISTH 2005:

Monday, 8th August: 9.00-18.30. Presenter available 16.00-17.00

Pharmacokinetics and Pharmacodynamics of TGN 167, a Novel Oral Direct Thrombin Inhibitor. Posterboard number: P0428. Anticoagulant Activity of TGN 255, a Novel Synthetic Direct Thrombin Inhibitor: P0516

Tuesday, 9th August: 9.00-18.30. Presenter available 17.00-18.30

Pharmacodynamics of TGN 255, a Novel Intravenous Low Molecular Weight Direct Thrombin Inhibitor. Posterboard number: P1115.

Pharmacokinetics and Pharmacodynamics of TGN 255, a Novel Intravenous Direct Thrombin Inhibitor. Comparison with Unfractionated Heparin. Posterboard number: P1116.

Wednesday, 10th August: 9.00-18.30. Presenter available 17.00-18.30

Effect of TGN 255, a Novel Intravenous Direct Thrombin Inhibitor, on the Prolongation of ACT in Patients Undergoing Haemodialysis. Posterboard number: P1614.

Pharmacokinetics of TGN 255, a Novel Intravenous Low Molecular Weight Direct Thrombin Inhibitor. Posterboard number: P1714.

Ecarin Clotting Time Profile Of TGN 255, A Novel Synthetic Intravenous Direct Thrombin Inhibitor. Posterboard number: P1715.

Thursday, 11th August: 9.00-18.30. Presenter available 17.00-18.30

The Utility Of TGN 255 In A Model Of Coronary Pulmonary Bypass And Simulated Mitral Valve Repair In The Dog. Posterboard number: P2305.

Identification And In Vitro Characterization Of TGN 255, A Novel Synthetic Intravenous Low Molecular Weight Direct Thrombin Inhibitor. Posterboard number: P2306

http://hugin.info/133328/R/1005395/154827.pdf

-0- Trigen Ltd. Ashley Tapp, Head of Corporate Communications Tel: +44 (0) 20 7004 2653 Mbl: +44 (0) 7944 570387 Email: atapp@trigen.co.uk

Copyright © 2005 PrimeZone Media Network, Inc.

Source: PrimeZone Media Network

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