Encouraging Immune Response Seen in ''Prime/Boost'' Phase I HIV Vaccine Study
Wednesday September 7, 12:15 pm ET
Booster Vaccine Developed by GenVec and NIH Vaccine Research Center
GAITHERSBURG, Md.--(BUSINESS WIRE)--Sept. 7, 2005--GenVec, Inc. (Nasdaq:GNVC - News) announced that preliminary safety and immune response data in a limited sample size of eight healthy volunteers enrolled in one of several ongoing Phase I clinical trials involving an HIV vaccine candidate developed by GenVec and the Vaccine Research Center (VRC) of the National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), showed that the vaccine regimen combining DNA priming and adenovector boosting was well tolerated and produced a vigorous cellular and antibody immune response. These preliminary findings were presented today at the AIDS Vaccine 2005 International Conference in Montreal, Canada by Barney S. Graham, M.D., Ph.D., the VRC study investigator.
In this study, the anti-HIV response was elicited in eight healthy volunteers who received a DNA prime vaccine followed by an adenovector-based booster vaccine shot. In subjects who had received prior DNA priming, cellular and antibody responses were several fold higher following the adenovector vaccine booster than in subjects who had received either DNA alone or the adenovector vaccine alone. The booster was administered up to 26 months after the DNA prime vaccine.
Both the DNA prime and adenovector-based booster vaccines included DNA segments for three major HIV subtypes, or "clades" (clades A, B, and C), responsible for 90% of HIV infections worldwide. Immune responses were detected to each of the HIV subtypes.
The adenovector-based booster vaccine was developed under a CRADA between GenVec and the NIAID Vaccine Research Center, and was constructed using GenVec's proprietary adenovector technology and the Company's 293-ORF6 production cell line, and codon modified gene inserts developed by the NIAID Vaccine Research Center. GenVec produced the related clinical supplies under a $40 million subcontract that extends through 2008. This subcontract was funded by the NIAID Vaccine Research Center, and issued and managed by SAIC-Frederick under an NCI contract. All early phase clinical testing is being conducted under the auspices of NIAID and its partner clinical trial networks. NIAID, along with its partner clinical trial networks, anticipates initiating multiple Phase II HIV vaccine trials later this year.
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.
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Contact:
GenVec, Inc.
Rena Cohen, 240-632-5501
rcohen@genvec.com |
