LONDON - Eurogene Ltd. is to move its collar reservoir device for local gene delivery into a Phase I study in blood vessel hyperplasia. The device, inserted at the time of surgery, will deliver a gene for Vascular Endothelial Growth Factor (VEGF) via the outside surface of blood vessels using a lipid delivery system. The study is designed to demonstrate that the VEGF gene will transfect and be expressed in the smooth muscle cells of the vessel wall and that the VEGF protein produced inhibits the proliferation of smooth muscle cells.

Alan Boyd, director of development at London-based Euro gene, told BioWorld International, "At the time of vascular surgery, the collar is placed over the join. It biodegrades within 28 days. In the meantime, the increase in VEGF levels brought about by the gene prevents the development of hyperplasia."

Eurogene says this is the first study in humans to investigate local delivery of a gene from outside the tissue, using such a biodegradable collar device, and a nonviral, liposomal vector. Delivery in this way is aimed at enhancing local gene delivery while limiting systemic exposure. The vector is produced by Valentis Inc. of Burlingame, Calif., which already has demonstrated that it can be used with VEGF for vascular applications.

Hyperplasia is a frequent complication after vascular surgery, resulting in the blockage of the vessels in up to 60 percent of patients. It is triggered by the surgery and insult to the vessels. The VEGF protein increases the production of nitric oxide in the endothelium, which, in turn, is responsible for inhibiting smooth muscle cell proliferation.

The trial will be carried out in three hospitals in Finland under the supervision of Seppo Yla-Herttuala, Eurogene's director of gene therapy, who is professor of molecular medicine at the University of Kuopio.

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