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GenVec phase 1 study demonstrates halt in progression of eye disorder
By Lisa Kerner
Erie, Pa., Feb. 7 - GenVec, Inc. said its phase 1 clinical study of AdPEDF gene therapy showed a halt in the progression of the eye disorder advanced neovascular age-related macular degeneration (AMD).
The halt in the disease progression lasted six to 12 months in 28 patients who received a single intravitreous injection of AdPEDF, according to a company news release.
The phase 1 multi-center, open-label, dose-ranging study was not designed to show efficacy.
Patients in the group that received higher doses of AdPEDF showed no increase in the size of retinal lesions at six and 12 months post-injection, compared to patients in the lower-dose group whose lesions increased over time.
Visual acuity in patients in the higher dose group was stable for the entire 12 months of the study, while those treated in the lower dose group appeared to show deterioration at six and 12 months.
GenVec said there were no serious adverse events, severe ocular inflammation or dose-limiting toxicities reported.
AdPEDF is an adenoviral-based vector containing the gene for human pigment epithelium-derived factor (PEDF), a protein which regulates blood vessel growth in the eye and protects the cells of the retina from damage, according to the release.
The study results were published in the February issue of Human Gene Therapy.
AMD is a loss of vision caused by the death of photoreceptors and retinal pigmented epithelial cells, caused by the growth of new blood vessels and fluid around the retina.
GenVec is a Gaithersburg, Md., biopharmaceutical company developing novel gene-based therapeutic drugs and vaccines.
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