SOURCE: Trigen

February 06, 2007 02:00 ET

Trigen opens IND for the initiation of a Phase III programme for flovagatran (formerly TGN 255), its novel intravenous direct thrombin inhibitor (DTI)

LONDON, UK -- (MARKET WIRE) -- February 6, 2007 --



Munich, Germany, and London, UK, 6 February 2007 - Trigen, the cardiovascular drug discovery and development company, today announced that following completion of appropriate regulatory procedures at the United States Federal Drug Administration (FDA), the Investigational New Drug (IND) application for flovagatran (formerly TGN 255) is open. Flovagatran is the company's novel intravenous direct thrombin inhibitor (DTI). Trigen intends to initiate the registration programme for flovagatran in the USA and other countries by studying the drug's ability to prevent thrombosis (clotting) in the extracorporeal circuit of haemodialysis patients.

Flovagatran has been evaluated successfully in a Phase II trial for the prevention of clotting in haemodialysis. It is being initially developed for haemodialysis patients with heparin-induced thrombocytopenia (HIT), a potentially dangerous immunological reaction which overrides the normal anti-coagulant effect of heparin and instead increases the overall risk of thrombosis. The Phase III programme consists of three randomised, multi-centre, multi-country studies which will examine the efficacy and safety of flovagatran relative to standard treatments in patients who can receive heparin as well as those with HIT.

Dr Tony Kennedy, VP Development at Trigen commented, "This is an important step forward for the flovagatran development programme. Being in a position to begin trials in the USA and commence the late-stage development programme constitutes a major milestone".

Dr Sophie Combe, VP Clinical Development at Trigen said, "We are encouraged by the clinical data on flovagatran so far. With this key step we are now looking forward to beginning the Phase III programme for the drug candidate in the haemodialysis setting. Furthermore, it is pleasing to see the level of interest being generated by flovagatran as a potential new anti-coagulant option."


About Trigen

Trigen is a biopharmaceutical company, with operations in London and Munich and a leader in cardiovascular drug discovery and development, focusing on thrombosis and vascular dysfunction. Its product pipeline includes clinical-stage candidates, flovagatran and PR-15. The company also has an exciting portfolio of pre-clinical and discovery stage programmes targeting thrombosis, atherosclerosis and other cardiovascular pathologies. In addition, Trigen benefits from two established discovery platforms, SIGSCREEN® and THROMSCAN® which have been applied in collaborations with a number of multinational pharmaceutical companies. For further information on Trigen please refer to the company website at http://www.trigen.co.uk or http://www.trigen.de.


About flovagatran

Trigen's lead product, flovagatran (formerly TGN 255), is a novel direct thrombin inhibitor which is being developed as a safer, more predictable and more convenient anti-coagulant for in-hospital indications. It is a highly selective, reversible and predictable agent which has already demonstrated in pre-clinical and clinical studies the potential to become a true 'on-demand' anti-coagulant. In particular, Trigen has demonstrated that with flovagatran, anti-coagulation can be rapidly established and stably maintained without dose adjustment. In addition, on cessation of therapy flovagatran is rapidly and predictably cleared. Furthermore, the product is approximately 85% non-renally excreted, suggesting that standard doses may be used in renally compromised patients (a majority of coronary artery disease (CAD) patients also suffer from chronic kidney disease). This profile suggests that flovagatran has the potential to become an important new anti-coagulant option. In particular, it presents an opportunity to address the significant unmet medical need for a safer and more predictable anti-coagulant in patients with CAD, as well as in patients with end-stage renal disease (ESRD).


Contact Details:

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

Mary Clark/Halina Kukula
Capital MS&L
Tel: +44 (0)20 7307 5336/5330
Email: mary.clark@capitalmsl.com
       halina.kukula@capitalmsl.com

Notes for Editors

An Investigational New Drug (IND) Application is a request made to the United States Food and Drug Administration (FDA) for authorization to administer an investigational drug or biological product to humans. Authorization must be secured prior to interstate shipment and administration of any new drug or biological product that is not the subject of an approved New Drug Application or Biologics/Product License Application. Further information on the IND process can be found on the Federal Drug Administration (FDA) website at http://www.fda.gov/cder/regulatory/applications/ind_page_1.htm.





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