GenVec finishes enrollment for AdPEDF study for macular degeneration

By Elaine Rigoli

Tampa, Fla., March 7 - GenVec, Inc. announced Tuesday the completion of enrollment in the company's follow-on phase 1 study of its AdPEDF gene therapy in patients diagnosed recently with wet age-related macular degeneration (AMD).

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.

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

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 12 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 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 1 open-label, dose-ranging clinical study of AdPEDF in 28 patients with advanced AMD were published in the February 2006 issue of Human Gene Therapy. Patients in that study showed evidence of a halt in disease progression lasting six to 12 months after a single intravitreous injection of AdPEDF.

GenVec is a biopharmaceutical company based in Gaithersburg, Md.

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