Business Wire - October 11, 2005
The double-blind, placebo-controlled Phase II study will enroll a total of 480 healthy volunteers who will be randomized 1:1 to receive either vaccine or placebo. The treatment group will receive a DNA plasmid injection (the "prime") followed by the adenovector-based booster vaccine. Both vaccines contain DNA segments from the three major HIV subtypes, or "clades," responsible for approximately 85 percent of HIV infections worldwide. The placebo group will receive saline injections. The trial is anticipated to include volunteers in the U.S., Haiti, Brazil, Trinidad, South Africa and Botswana.
GenVec produced the adenovector vaccine under a $50 million subcontract that extends through 2008. This subcontract was funded by the VRC, and issued and managed by SAIC-Frederick under an NCI contract. Clinical testing is being conducted under the auspices of NIAID and its clinical trial networks.
GenVec is a publicly held clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies that improve patient care in the areas of cancer and cardiac disease, and to prevent vision loss. GenVec's vaccine program applies the Company's unique delivery technology and 293-ORF6 cell line to develop vaccines against a variety of diseases, including HIV, malaria, and foot and mouth disease. The vaccine candidate discussed in this release has not been approved by the U.S. Food and Drug Administration or any other regulatory agency. GenVec is not responsible for the design or conduct of the clinical trials discussed in this release. Additional information on GenVec 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.
CONTACT: GenVec, Inc.
Rena Cohen, 240-632-5501
rcohen@genvec.com
SOURCE: GenVec, Inc.
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