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Taberminogene vadenovec (EG004) is a novel product consisting of a local delivery device and a gene-based medicine, being developed to prevent the blocking of veins and arteries that frequently occurs after vascular surgery. The initial target market is haemodialysis graft access surgery, a procedure in which patients whose kidneys have failed have a plastic tube grafted between blood vessels generally in their forearm so that their blood can be regularly filtered using a dialysis machine. EG004 has completed a Phase II trial, this being the first part of the Phase II/III study for which it has received approval from the US Recombinant DNA Advisory Committee (RAC).
Taberminogene vadenovec (EG004) is a novel product consisting of a local delivery device and a gene-based medicine, being developed to prevent the blocking of veins and arteries that frequently occurs after vascular surgery. The initial target market is haemodialysis graft access surgery, a procedure in which patients whose kidneys have failed have a plastic tube grafted between blood vessels generally in their forearm so that their blood can be regularly filtered using a dialysis machine. EG004 has completed a Phase II trial, this being the first part of the Phase II/III study for which it has received approval from the US Recombinant DNA Advisory Committee (RAC).
EG004 is a combination of a vascular endothelial growth factor (VEGF-D) gene packaged in an adenoviral vector (Ad 5) and a bio-degradable local drug delivery device made from collagen and invented by Ark. At the end of access graft surgery, the delivery device is fitted around the outside of the patient's vein where it has been joined to the access graft. The adenoviral vector carrying the VEGF gene is then injected into a space between the device and the blood vessel. This unique administration of the gene to the outside of the blood vessel rather than into the blood supply localises delivery of the gene to the target tissue site (smooth muscle cells) and reduces the risk of unwanted systemic effects. Once the VEGF gene is transfected locally, muscle cells in the vessel wall produce the VEGF protein which triggers the release of beneficial nitric oxide and prostacyclin. Ark has made a novel discovery by showing that the VEGF protein working via these two agents has a protective effect in vivo, keeping blood vessel walls in a healthy state and regulating muscle cell growth to prevent blocking of the vessel.
Investigated for use/treatment in cardiovascular disorders and kidney disease.
每项发明一条,涵盖美国、欧洲、PCT 与中国的同族专利。
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