LONDON, Dec. 09, 2003 (PRIMEZONE) -- Trigen Ltd today announced that preclinical studies with a neutralising agent showed a specific, rapid and complete reversal of the anti-coagulant properties of its direct thrombin inhibitors (DTIs), TGN 167 (oral) and TGN 255 (intravenous) which are both in clinical development. Data was presented at the American Society of Hematology (ASH) in San Diego, California.
Trigen's discovery group has exploited this breakthrough by identifying a low molecular weight synthetic neutralising candidate, TGN 212, which will be progressed further in preclinical development in 2004.
"Whilst the newer generation of direct acting thrombin inhibitors, including Trigen's DTIs, appear to have lower bleeding rates than traditional agents, all anti-coagulants carry a degree of bleeding risk. Therefore, there are instances where it is desirable to neutralise their activity rapidly and predictably, for example, in emergency situations or during elective surgery," said Dr. Sophie Combe, Trigen's VP Clinical Development. "We therefore plan to develop TGN 212 in parallel with TGN 167 and TGN 255 to provide physicians with novel anti-coagulants whose effect can be neutralised in both emergency out-patient and operative situations."
"We have already demonstrated a low bleeding potential for our novel DTIs. However, this important development brings us further competitive advantage as we now have the only novel oral and intravenous anti-coagulants in development for which there will be a specific neutralising agent," said Dr. Sanjay Kakkar, Trigen's Chief Executive Officer. "We therefore plan to offer new anti-coagulation treatment options not just in traditional areas of therapy but also in currently untreated populations which even the newer anti-coagulant agents cannot serve because of their low specificity and lack of antidote."
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:
Whilst the risk of bleeding with newer anti-coagulant agents appears to be potentially lower than with traditional agents, physicians would still prefer to be able to reverse anti-coagulant activity with a neutralising agent. In particular, when prescribing anti-coagulants for chronic out-patient use in patients with a higher risk of bleeding -- for example the elderly -- the availability of an effective neutralising agent would give the physician added confidence. Furthermore, in certain elective operative procedures calling for high levels of anti-coagulation, rapid reversal at the end of the procedure is mandatory. To date, standard unfractionated heparin is the only anti-coagulant used in such procedures as it is the only product for which there is a neutralising agent.
Trigen has two products from its DTI programme in clinical trials, TGN 167 (oral) and TGN 255 (intravenous). Based on extensive preclinical and clinical trials, both formulations have been found to be potentially effective in both venous and arterial indications. Trigen's DTI is a synthetic small molecule and is the only DTI in development today with a specific neutralising agent.
For further information and to view the poster containing the presentation data please visit www.trigen.co.uk
To view this press release in pdf format, please click on the link below.