West Nile Virus DNA Vaccine Enters Human Trial
Equestrian News Release
SAN DIEGO, April 19 /PRNewswire-FirstCall/ -- Vical Incorporated (NASDAQ:VICL) announced today that initial human testing of an investigational vaccine targeting West Nile virus (WNV) has begun at the National Institutes of Health's (NIH) Clinical Center in Bethesda, MD. The vaccine, based on Vical's proprietary DNA delivery technology, was co-developed at the National Institute of Allergy and Infectious Diseases' (NIAID) Vaccine Research Center (VRC) and at Vical. Vical manufactured research and clinical supplies of the vaccine, and has an option to exclusive commercialization rights.
Vical's President and Chief Executive Officer, Vijay B. Samant, said, "We are pleased with the continued progress under our collaboration with the NIH, with four vaccine programs that have now advanced to human clinical testing. Leveraging the inherent advantages of our DNA delivery technology, we have rapidly constructed vaccines and advanced them to human testing. The development time and safety advantages of our technology may be critically important for emerging diseases, which often spread rapidly and are potentially life-threatening."
The WNV vaccine encodes two key surface proteins of the West Nile virus. A similar vaccine construct was shown in independent tests at the U.S. Centers for Disease Control and Prevention to protect horses from WNV after a single injection. The trial will enroll 15 healthy adult volunteers, who will each receive three injections at approximately four-week intervals. Subjects will be monitored for safety and immune responses against the encoded WNV proteins.
About West Nile Virus
West Nile virus has been an increasing seasonal threat in the United States over the past several years, causing growing numbers of cases in birds, horses, and humans each summer. The disease is spread by many species of mosquitoes, which carry the virus from reservoirs to humans. Most infected people have no disease symptoms, and some have only mild symptoms. But approximately one out of every 150 infected people develops serious disease symptoms of the central nervous system, such as headache, high fever, tremors, convulsions, numbness, vision loss, coma, and paralysis lasting several days to several weeks, potentially with some permanent neurological damage. Most West Nile virus deaths are caused by encephalitis, a severe swelling of the brain, or meningitis, a severe swelling of the membrane surrounding the brain and spinal cord.
Conventional vaccines, using whole killed West Nile virus, are available for horses and for some species of birds. To develop a human vaccine using this approach, however, could require many years of further development and testing to provide sufficient proof of safety and effectiveness.
About Vical
Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Potential applications of the company's DNA delivery technology include DNA vaccines for infectious diseases or cancer, in which the expressed protein is an immunogen; cancer immunotherapeutics, in which the expressed protein is an immune system stimulant; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor. The company has retained all rights to its internally developed product candidates. In addition, the company collaborates with major pharmaceutical companies and biotechnology companies that give it access to complementary technologies or greater resources. These strategic partnerships provide the company with mutually beneficial opportunities to expand its product pipeline and serve significant unmet medical needs. Additional information on Vical is available at http://www.vical.com.
This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements about the advantages of using Vical's DNA delivery technology in the development of vaccines against WNV or other infectious diseases, the makeup, development, uses and beneficial effects of such vaccines, and the option to exclusive commercialization rights to the WNV vaccine, as well as the company's focus, collaborative partners, product candidates, and developmental status. Risks and uncertainties include whether vaccines for WNV or other infectious diseases will be developed and approved, whether use of Vical's technology in such vaccines will provide protective immune responses to such diseases and will result in products that are safer, simpler and faster to manufacture than traditional vaccines, whether any product candidates will be shown to be safe and efficacious in clinical trials, the timing of clinical trials, whether Vical or its collaborative partners will seek or gain approval to market any product candidates, the dependence of the company on its collaborative partners, and additional risks set forth in the company's filings with the Securities and Exchange Commission. These forward-looking statements represent the company's judgment as of the date of this release. The company disclaims, however, any intent or obligation to update these forward-looking statements.
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