ROCKVILLE, Md., April 02, 2007 /PRNewswire-FirstCall/ -- Novavax Inc.'s virus- like particle (VLP) vaccine triggered a robust immune response and provided protection against the H9N2 strain of avian influenza, according to pre- clinical data published in the online edition of the journal Vaccine.
Novavax's vaccine was tested in three animal models, including the ferret, which is the most predictive model for influenza vaccine effectiveness in humans. Ferrets experience flu symptoms very similar to people who are infected with the virus. Protection, as measured by a reduction in viral load, was assessed in vaccinated ferrets challenged with live H9N2 avian influenza. Like the H5N1 strain, the H9N2 strain initially spread among domestic poultry in Asia. Since then, it has been isolated from humans and is identified as having pandemic potential.
"This is the first time Novavax has measured the efficacy of our VLP vaccine against a live virus challenge in the very important ferret model," said Dr. Rick Bright, vice president of global influenza programs at Novavax. The Company previously conducted live virus challenge studies with the H5N1 strain in mice. "These data are very encouraging because the ferret is a more predictive model for efficacy in humans."
Virus-like particles mimic the three-dimensional structure of a virus but do not contain genetic material, so they cannot replicate or cause infection. As VLPs maintain functional properties of both influenza surface proteins (hemagglutinin and neuraminidase), they likely trigger multiple arms of the immune system to generate a broadly protective immune response.
Novavax has conducted several pre-clinical studies evaluating a number of its VLP vaccines against different strains of avian influenza. "All of the data we've accumulated to dat e indicate that our VLP vaccines have the potential to provide protection against various strains of avian influenza," Dr. Bright said. "We are particularly encouraged by these ferret data and look forward to evaluating the immunogenicity of our H5N1 VLP vaccine in the clinic later this year."
The study was conducted in collaboration with Dr. Terrence Tumpey of the Center for Disease Control and Prevention's Influenza Division based in Atlanta, GA. As part of the study, Novavax also evaluated its proprietary Novasome adjuvant with both the H9N2 VLP vaccine and a recombinant hemagglutanin antigen vaccine. Both vaccines combined with adjuvant were shown to provide protection in mice. Adjuvants are used to improve the efficacy of vaccines and may help reduce the dosage required for protection in a pandemic setting.
The study appears in the online version of the peer-reviewed journal Vaccine and is currently available at http://tinyurl.com/2q9wla. The print edition will be published shortly.
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.
Forward Looking Statements
Statements herein relating to future financial or business performance, cond itions or strategies and other financial and business matters, including expectations regarding future revenues, product safety or efficacy, patent protection, 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 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 Inc., +1-240-268-2029
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