PRNewswire-FirstCall (Apr 28, 07:05 AM) GAITHERSBURG, Md., April 28 /PRNewswire-FirstCall/ -- GenVec, Inc. , a biopharmaceutical company, announced that Peter A. Campochiaro, M.D., Professor of Ophthalmology and Neuroscience, Wilmer Eye Institute, Johns Hopkins School of Medicine and Principal Investigator for the Company's clinical study of AdPEDF, presented interim results of the Phase I trial of AdPEDF in patients with severe wet age-related macular degeneration (AMD). The data were presented Tuesday evening during the Age-Related Macular Degeneration session at the Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO) in Ft. Lauderdale, Florida.
The Phase I, multi-center, dose escalation study in patients with severe wet AMD demonstrated that AdPEDF was well tolerated at all dose levels, including patients treated at the highest dose. No dose limiting toxicities or drug related serious adverse events have been observed to date. In addition, no cases of significant ocular inflammation or endophthalmitis (infection) were reported. This interim data reports on 24 patients treated to date who received a single intravitreal injection of AdPEDF. Dose escalation in this study has increased by 3,000 fold from the initial dose. Investigators observed positive changes in visual acuity and retinal appearance at the higher dose levels. A series of visual and biological tests were performed, including regular ophthalmalic exams, standard clinical and laboratory function tests, and intraocular pressure (IOP) measurements, to determine safety in this study.
"We are very encouraged by the safety profile of AdPEDF and the investigators' observation of changes in visual acuity and retinal appearance," commented Paul D. Kessler, M.D., Executive Director of Clinical Research at GenVec. Dr. Kessler continued, "These data indicate that further clinical testing of AdPEDF in patients with less severe macular degeneration is the logical next step."
GenVec will also be making several pre-clinical presentations during the ARVO meeting, including data on alternative deliveries of AdPEDF, repeat adenovector dosing, and activation of gene expression.
GenVec is a publicly held biopharmaceutical company developing novel therapies that are intended to improve patient care in the areas of cancer, heart disease, and vision loss. GenVec also has funded vaccine programs for HIV, SARS, malaria and dengue virus. Additional information on GenVec is available at http://www.genvec.com/ and in 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 revenues and operating expenses, 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 and uncertainties, including the failure by GenVec to secure and maintain relationships with collaborators; risks relating to the early stage of GenVec's product candidates under development; uncertainties relating to clinical trials; 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 http://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.
GenVec, Inc.
CONTACT: Virginia M. Dunn, Corporate Communications of GenVec, Inc.,+1-301-944-1172, or gdunn@genvec.com
Web site: http://www.genvec.com/
