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GAITHERSBURG, MD, USA | Mar 07, 2006 | GenVec, Inc. (Nasdaq: GNVC) announced today the completion of enrollment in the company’s follow-on Phase I study of its AdPEDF gene therapy in patients diagnosed recently with wet age-related macular degeneration (AMD). This 9-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 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 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 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.
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 |
