GenVec completes enrollment in eye disease trial

This nine-center clinical trial involves 20 patients who received a single injection of one of two doses of AdPEDF. Study participants will be evaluated at three and twelve weeks to assess changes in their vision and to confirm the drug’s safety profile and will then be followed for one year after treatment.

The trial includes several patients with refractory wet age-related macular degeneration (AMD) who were treated previously with approved therapies but continued to lose vision, a problem in more than two-thirds of patients with AMD who receive treatment with anti-VEGF or photodynamic therapies.

Results of the company’s earlier phase I dose-ranging study showed evidence of a halt in disease progression lasting six to twelve months after a single intravitreous injection of AdPEDF.

AdPEDF is an adenoviral-based vector containing the gene for human pigment epithelium-derived factor (PEDF), a protein found in the eye that normally regulates blood vessel growth in the eye and protects the cells of the retina from damage.

AMD is a loss of vision caused by the death of photoreceptors and retinal pigmented epithelial cells that occurs when new abnormal blood vessels grow and pockets of fluid form around the retina. Vision loss is potentially reversible at this stage of disease if the growth process can be stopped and fluid resorption takes place. The disorder affects almost thirty percent of adults between the ages of 75 and 85.

New therapies to treat AMD have demonstrated benefit but these therapies must be injected every four to six weeks. GenVec believes its gene transfer approach may provide an effective and more convenient treatment for AMD.