LONDON, Dec. 16, 2003 (PRIMEZONE) -- Trigen Ltd today announced the successful completion of a Phase I dose escalation study for its highly selective oral direct thrombin inhibitor (DTI), TGN 167, which is being developed for the prevention and treatment of thrombosis. Trigen is developing TGN 167 for safe, effective, predictable and convenient anti-coagulation for chronic out-patient use.
In a 20 volunteer, placebo-controlled study conducted in the UK, TGN 167 was well tolerated at all doses, with no significant adverse events reported. "The study demonstrated that TGN 167 has the desired pharmacodynamic properties of an oral anti-coagulant, namely, a marked increase in thrombin clotting time, highlighting the potential efficacy of the drug, with minimal effects on aPTT, which is a measure of potential bleeding risk in a clinical situation." said Sophie Combe, MD, Trigen's VP of Clinical Development.
"The required attributes for a 'Best-in-Class' oral anti-coagulant for out-patient use are efficacy, safety and no need for monitoring, whether for anti-coagulation or for side effects," said Sanjay Kakkar MD, Trigen's Chief Executive Officer. "The profile we have seen for TGN 167 in the recently completed Phase I study demonstrates that it is possible, using an oral agent, to offer powerful anti-coagulant cover without increasing bleeding risk. We are very pleased with the overall safety profile of TGN 167."
Trigen will advance TGN 167 into Phase II clinical studies during 2004 in parallel with the selection of a preferred partner for the product's later stage development and marketing.
Trigen has recently reported the successful completion of a Phase I dose escalation study for its intravenous direct thrombin inhibitor, TGN 255, for in-hospital and acute care indications. In addition, Trigen has recently presented preclinical studies of a neutralising agent for the specific, rapid and complete neutralisation of the anti-coagulant properties of both TGN 167 (oral) and TGN 255 (intravenous).
Trigen is a private UK biotechnology company, based in London, that discovers and develops novel drugs for the management of occlusive and inflammatory cardiovascular diseases. Trigen's lead programme, comprising a series of anti-coagulant direct thrombin inhibitors (DTIs) for the prevention and treatment of thrombosis, is in clinical development in both intravenous and oral formulations. In addition Trigen has other programmes, focused on thrombosis and ischaemia-related diseases, in preclinical development.
The market can be broadly divided into three major classes: thrombolytics, anti-platelet agents and anti-coagulants. Trigen is currently focused on developing anti-coagulants, the class with the widest variety of applications in venous and arterial occlusions (blockages), both acute and chronic.
Within the class of anti-thrombotic therapy, the development of novel oral anti-coagulants for chronic, long-term treatment constitutes the greatest commercial opportunity. This is because the only oral anti-coagulant currently available for long-term prevention of thrombosis is warfarin. Warfarin has many disadvantages, including a tendency to interact adversely with many other drugs and a high degree of variability in its efficacy between patients and in individual patients over time. As a result, warfarin treatment must be monitored very closely, an inconvenience for the large number of patients who are taking the drug for life and a considerable cost to healthcare payers. There is consequently a pressing need for better oral agents to replace warfarin with a drug that does not require monitoring. The pharmaceutical industry has identified this medical need as offering a major cardiovascular "blockbuster" opportunity.
For further information, please visit www.trigen.co.uk
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