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Novavax Announces Enrollment in the Second Phase II Study of its Seasonal Influenza VLP Vaccine Candidate
Date:5/5/2009

e neuraminidase or "NA" proteins, which stimulate the body to produce antibodies that neutralize influenza virus and prevent spread throughout the cells of the respiratory tract -- and the matrix 1 or "M1" virus that stimulates cytotoxic T lymphocytes to kill cells that may already be infected. This three-pronged approach may offer an advantage over existing vaccines which contain mostly HA with variable and typically low quantities of NA and M1. Further, the VLPs are not made from a live virus and have no genetic material in their inner core, which renders them incapable of replicating and mixing with other influenza viruses.

The current study was planned before the recent outbreak of the 2009 H1N1 influenza virus in North America, which has since spread around the globe. In response to the outbreak, Novavax is making a VLP vaccine candidate against the outbreak strain. Using Novavax's recombinant technology, the VLPs will be genetically matched to the H1N1 influenza strain recommended by CDC, with the potential to induce specific and protective immunity. Further, the VLP approach has the potential of a rapid response as vaccine may be made and released for administration within 12 weeks of knowing the genetic sequence of the outbreak strain.

"We are delighted to have initiated the second clinical study of our seasonal influenza vaccine program", said Dr. Rahul Singhvi, President and CEO of Novavax. "The initiation of this study of the 2008-2009 VLP vaccine highlights our ability to create and manufacture VLPs against multiple influenza strains. Including this study, we now have created and evaluated the safety and immunogenicity of VLPs against seven different strains of influenza in clinical trials. This experience has been of great value as we continue our efforts to create a VLP vaccine against the recently emerged 2009 H1N1 influenza virus".

About Novavax

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