New Data Support Novavax's Pandemic Flu VaccinesFirst Data From Live-Virus Challenge Study Show Robust Immune Response and Cross-Protection in Pre-Clinical Models
BALTIMORE, January 22, 2007 /PRNewswire-FirstCall/ -- Novavax, Inc.'s novel virus-like particle (VLP) vaccines have been shown to be effective in generating protection against pandemic influenza as well as cross protection against different strains of the virus in pre-clinical studies, according to data presented here today at the Phacilitate Vaccine Forum.
"These are the first live-virus challenge data we have presented," said Dr. Rick Bright, Novavax's Vice President of Global Influenza Programs. "These new data are exciting because not only do our VLP vaccines trigger a robust immune response, but we have shown that a single vaccine can protect against two different strains of pandemic influenza."
The studies involved two of Novavax's H5N1 influenza VLP vaccines - one targeting the Indonesia strain of pandemic flu, first identified in 2005, and another targeting the Viet Nam strain, identified in 2003.
Both mice and ferrets inoculated with the Indonesia VLP vaccine showed a robust immune response in the study. When challenged with both the Indonesia and Viet Nam strains, the animals were protected against both viruses.
The ferret is the most relevant animal model for influenza because ferrets exhibit similar clinical symptoms as humans and are naturally susceptible to most human influenza viruses, including H5N1. "Ferrets are the most predictive model used for evidence of immunogenicity of influenza vaccines for humans," Dr. Bright said.
In addition, Novavax has shown that mice inoculated with the Viet Nam strain of the company's VLP vaccine were protected from that strain as well as from the Indonesian strain of pandemic influenza.
"These new data give us more confidence as we prepare to enter human clinical trials with our pandemic vaccine later this year," Dr. Bright said. "We also are increasingly confident about our ability to generate similar results in our seasonal influenza vaccine program as it progresses in pre-clinical testing."
The challenge studies were conducted in collaboration with the University of Pittsburgh, and the data have been submitted for peer-review publication. In addition, the U.S. Centers for Disease Control and Prevention (CDC) will conduct live challenge studies using Novavax's VLP pandemic influenza vaccines.
"We expect the CDC to further confirm these new data before we enter the clinic this year," Dr. Bright said.
Novavax Inc. is committed to leading the global fight against infectious disease by creating novel, highly potent vaccines that are safer and more effective than current preventive options. Using the company's proprietary virus-like particle (VLP) and Novasome(R) adjuvant technologies, Novavax is developing vaccines to protect against H5N1 pandemic influenza, seasonal flu and other viral diseases. Novavax's particulate vaccines closely match disease-causing viruses while lacking the genetic material to cause disease, which provides potential for greater immune protection at lower doses than current vaccines. With an exclusive portable manufacturing system that allows for rapid mass-production of vaccines, Novavax is uniquely positioned to meet global public health needs.
Statements herein relating to future financial or business performance, conditions or strategies and other financial and business matters, including expectations regarding future revenues, operating expenses, and clinical developments are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Novavax 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 Novavax to secure and maintain relationships with collaborators; risks relating to the early stage of Novavax's product candidates under development; uncertainties relating to clinical trials; risks relating to the commercialization, if any, of Novavax's proposed product candidates; dependence on the efforts of third parties; dependence on intellectual property; competition for clinical resources and patient enrollment from drug candidates in development by other companies with greater resources and visibility, 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 Novavax's business, financial conditions and results of operations, is contained in Novavax's filings with the U.S. Securities and Exchange Commission, which are available at http://www.sec.gov. These forward-looking statements speak only as of the date of this press release, and Novavax assumes no duty to update forward-looking statements.
CONTACT: Mariann Caprino of Novavax, +1-240-268-2029
Web site: http://www.novavax.com/
Ticker Symbol: (NASDAQ-NMS:NVAX)
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Posted: January 2007