понедельник, 9 мая 2011 г.

Novavax Vaccine Provides Robust Immune Response, Pre-Clinical Data Show

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 date 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 tinyurl/2q9wla.
















About Novavax



Novavax Inc. (Nasdaq: NVAX) 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,
conditions 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
sec. These forward-looking statements speak only as of the date of
this press release, and Novavax assumes no duty to update forward-looking
statements.


Novavax Inc.

novavax

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