LONDON, U.K., Dec. 03, 2003 (PRIMEZONE) -- Trigen Ltd today announced the successful completion of a Phase I dose escalation study for its intravenous direct thrombin inhibitor, TGN 255, which is being developed for the prevention and treatment of thrombosis. Trigen is developing TGN 255 for certain in-hospital and acute care indications where there is a need for safer and more convenient anti-coagulants than are currently available.
The study demonstrated that TGN 255 has the desired pharmacodynamic properties of an 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.
"The profile we have seen for TGN 255 in the recently completed Phase I study is ideal for a number of poorly served clinical indications in which Trigen can clearly demonstrate the benefits of TGN 255 with relatively small clinical trials. In this way we can bring TGN 255 rapidly to market to offer its benefits to patients," said Dr Sanjay Kakkar, Trigen's Chief Executive Officer. "Trigen will advance TGN 255 into Phase II and III clinical studies during 2004 in selected indications."
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.
Note to Editors:
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. Thrombosis, or the formation of a pathological blood clot, is the single largest cause of death and disability in the western hemisphere and is implicated in a wide range of medical conditions, including acute coronary syndromes (heart attack), stroke, deep vein thrombosis and peripheral arterial disease. In the USA, there are approximately 8.5 million acute events each year and an estimated chronic market population of 33 million. The anti-thrombotic market is large and growing; according to market research, anti-thrombotics generated sales of $8.9 billion in 2002 and sales are forecast to grow to over $17 billion by 2007.
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.
There is an unmet medical need in acute anti-coagulation where the mainstay of treatments suffers many disadvantages. Of greatest concern is the internal bleeding caused by these drugs if they are given at too high a dose, narrowing the therapeutic window in which they can be safely administered. Furthermore, the main drugs currently used, heparins, have several additional issues including their heterogeneous nature, variability in kinetics, indirect action, weak effect on clot-bound thrombin, monitoring requirement, allergic reactions, inactivation and their extraction from animal tissue.
Glossary
Thrombin: an enzyme that causes blood to clot by catalysing conversion of the soluble protein fibrinogen to the insoluble fibrin
Pharmacodynamic: the study of drug action on living organisms
Thrombolytic: a drug that breaks down a blood clot
Kinetics: the distribution of a drug in a system
aPTT: Activated Partial Thromboplastin Time, a test that measures the time required for a clot to form in a plasma sample under specific conditions