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GenVec Macular Degeneration Study and Supporting Editorial Published in February Issue of Human Gene Therapy

07 Feb 2006

GAITHERSBURG, MD, USA | Feb 07, 2006 | GenVec, Inc. (Nasdaq: GNVC) announced today the publication of results from a

Phase I clinical study of its AdPEDF gene therapy in 28 patients with advanced neovascular age-related macular degeneration (AMD), a debilitating eye disorder. The findings, published in the February 2006 issue of Human ene Therapy, showed evidence of a halt in disease progression lasting six to twelve months fter patients received a single intravitreous injection of AdPEDF. There were no serious adverse events, severe ocular inflammation or dose-limiting toxicities reported.

Although the Phase I 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 twelve 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 twelve months of the study, while those treated in the lower dose group appeared to show deterioration at six and twelve months. These findings suggest that a prolonged therapeutic effect may be achieved after a single injection of AdPEDF.

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. Previous animal studies have shown

the potential benefits of increasing PEDF expression in the eye to prevent the growth of blood vessels (angiogenesis) that leads to vision loss.

In a commentary published in the same issue of Human Gene Therapy, Jean Bennett, M.D., Ph.D., professor of ophthalmology, cell and developmental biology at the University of Pennsylvania School of Medicine, wrote, “It is encouraging that evidence of a sustained therapeutic effect was seen … after one intravitreal injection. One advantage of a gene therapy approach compared with other treatment paradigms is that the molecule is produced at high levels within the target tissue and over a prolonged period of time.” A copy of the publication and the supporting editorial can be found on GenVec’s website by selecting Webcasts & Data/Recent Data Presentations/PEDF.

AMD is a loss of vision caused by the death of photoreceptors and retinal pigmented epithelial cells that occurs when new 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.
GenVec, Inc. is a biopharmaceutical company developing novel gene-based therapeutic drugs and vaccines. Additional information on GenVec and its portfolio of product candidates is available at www.genvec.com and in the company’s various filings with the Securities and Exchange Commission.

Statements herein relating to future financial or business performance, conditions or strategies and other financial and business matters, including expectations regarding future programs and studies, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. GenVec cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks relating to the early stage of GenVec’s product candidates under development; uncertainties relating to clinical trials; the timing and content of future U.S. Food and Drug Administration regulatory actions with respect to GenVec, its product candidates, or collaborators, risks relating to the commercialization, if any, of GenVec’s proposed product candidates (such as marketing, regulatory, patent, product liability, supply,

competition and other risks); dependence on the efforts of third parties; dependence on intellectual property; and risks that we may lack the financial resources and access to capital to fund our operations. Further information on the factors and risks that could affect GenVec’s business, financial conditions and results of operations, are contained in GenVec’s filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. These forward-looking statements speak only as of the date of this press release, and GenVec assumes no duty to update forward-looking statements.

SOURCE: GenVec, Inc

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