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News
Release: August 22, 2006
GenVec Vaccine Technology Enters First HIV Human Therapeutic Clinical Trials at Vaccine Research Center at NIH
Study to Assess Effectiveness of a Vaccine Utilizing Boost Based on GenVec's Adenovector Technology and Proprietary Cell Line to Treat Patients Infected with Most Common Strains of HIV
GAITHERSBURG, Md.--(HSMN NewsFeed)--Aug. 22, 2006--GenVec, Inc. (Nasdaq:GNVC ) announced today that the first human therapeutic clinical trial involving the company's adenoviral-vector technology used in an HIV vaccine candidate will be conducted by the Vaccine Research Center (VRC), National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH) in Bethesda, MD. These will be the first human trials to assess the effectiveness of a "prime-boost" vaccine using GenVec's adenovector technology as a potential therapy for patients infected with HIV. The randomized, placebo-controlled study will measure safety and immunogenicity, in 15 HIV positive patients.
The trial will combine two components, a DNA prime vaccine and GenVec's adenovector-based technology used in the boost vaccine. The adenovector-based boost vaccine was developed using the company's proprietary technology and 293-ORF6 cell line. Patients in the study will be treated with the first vaccine (known as DNA prime) followed by a booster with the second vaccine (known as rAD5 boost), and will be evaluated for 48 weeks. The clinical trial will be conducted by the VRC as part of a broad effort to test HIV vaccines based on GenVec's adenovector delivery technology and cell line.
"We continue to see great promise for our proprietary adenovector delivery technology for the development of an effective HIV vaccine. In preclinical and clinical studies, our vaccine candidates have demonstrated a broad antibody and T-cell responses against HIV, clades A, B and C. We look forward to the completion of human studies to assess the effectiveness of these products as therapeutic options for patients," said Dr. Rick King, GenVec's senior vice president of research.
In October 2005, the VRC announced the initiation of Phase II testing of a prime/boost preventative vaccine utilizing GenVec's adenovector technology. In addition, seven Phase I trials of the preventative vaccine have completed enrollment and more than 600 healthy participants have received the adenovector vaccine candidate boost to date.
The rate of new HIV infections has continued to increase, particularly in developing countries. The Joint United Nations Programme on HIV/AIDS and the World Health Organization estimate that as many as 6.4 million new cases of HIV/AIDS were diagnosed and roughly 40 million people worldwide were living with HIV/AIDS at the end of 2004. As many as 30 million people worldwide have died as a result of HIV infection since the epidemic began.
GenVec, Inc. is a biopharmaceutical company developing novel gene-based therapeutic drugs and vaccines. GenVec has several adenovector (DNA carrier)-based vaccines currently in development against a variety of diseases, including HIV, malaria, pandemic flu and foot and mouth disease. 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.
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Source: GenVec
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