Ark Granted Patent in Europe for Trinam®
Ark Therapeutics Group plc announced that it has been issued with a patent by the European Patent Office for Trinam®, its novel therapy to prevent blood vessels blocking after vascular graft access surgery. Subject to the payment of renewal fees, this patent can be maintained until at least 2016.
Trinam® is a combination of a Vascular Endothelial Growth Factor (VEGF) gene in an adenoviral vector and Ark's biodegradable collagen collar local delivery device (EG001). The initial target market for Trinam® is haemodialysis access graft surgery, a treatment for kidney failure patients where a plastic tube is grafted between blood vessels in the forearm to enable regular blood filtration. At the end of the access graft surgery procedure, the EG001 delivery device is fitted around the outside of the vein where it had been joined to the access graft. The VEGF gene in solution is then injected into the reservoir formed between the delivery device and the blood vessel, from where it passes into the blood vessel wall, transfecting the smooth muscles cells in the wall - a process known as adventitial transfection. This unique method of administration allows Trinam® to be localised to the target site where the therapy is needed.
Preclinical studies have demonstrated a significant effect in preventing intimal hyperplasia and successful adventitial gene transfer. Trinam® is currently in Phase II clinical trials in the USA. The Phase II ascending dose study in up to 20 patients is designed to examine the efficacy and safety of Trinam® in patients undergoing haemodialysis access graft surgery.
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