Novavax, Inc.'s (Nasdaq:
NVAX) 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.
ABOUT NOVAVAX
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,
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 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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