Novavax Initiates Phase 2 Safety and Immunogenicity Trial of the RSV F Vaccine in Older Adults
January 19 2017 - 4:05PM
GAITHERSBURG, Md., Jan. 19, 2017
(GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) today announced the
initiation of a Phase 2 clinical trial of its respiratory syncytial
virus F-protein nanoparticle vaccine candidate (RSV F Vaccine) in
older adults (60 years of age and older).
The objective of the trial is to
assess safety and immunogenicity to one and two dose regimens of
the RSV F Vaccine, with and without aluminum phosphate or Novavax'
proprietary Matrix-M(TM) adjuvant, in older adults. The trial is a
randomized, observer-blinded, placebo-controlled trial designed to
enroll up to 300 older adults in the Southern Hemisphere.
Participants are being enrolled and vaccinated outside of the RSV
season to best assess immunogenicity. Top-line results are expected
in the third quarter of 2017.
"We believe that a more
immunogenic vaccine in the older adult population should translate
into a more efficacious vaccine," said Stanley C. Erck, President
and CEO. "We expect the results from this trial to inform the next
steps in our older adults program, and would ensure we maintain our
leadership position in this very attractive market
opportunity."
About RSV
Respiratory syncytial virus,
commonly referred to as RSV, is a respiratory infectious disease
that causes serious infection of the respiratory tract, similar to
influenza. For some, RSV may progress in severity, and lead to
hospitalization or even death. The spread of RSV occurs annually,
with an incidence rate of 2.5 million infections per year in the
United States, RSV is increasingly being recognized as a
significant cause of morbidity and mortality in the population of
64 million older adults.(1,2) Each year, RSV is responsible
for approximately 207,000 hospitalizations and 16,000 deaths among
adults older than 65.(1,3) Annually, there are approximately
900,000 medical interventions directly caused by RSV
disease.(4,5) Currently, there is no approved RSV vaccine
available.
About
Matrix-M
Matrix-M(TM) is a next-generation,
patented adjuvant comprised of purified saponin fractions mixed
with synthetic cholesterol and a phospholipid to form stable
particles than can be readily formulated with a variety of vaccine
antigens. Saponin-based adjuvants act in part by stimulating the
entry of antigen-presenting cells into the injection site and
enhancing antigen presentation in the local lymph nodes. Thus,
Matrix-M(TM) induces both a cell-mediated and antibody mediated
immune response. Matrix-M is manufactured by Novavax, Inc.,
in Uppsala Sweden.
About
Novavax
Novavax, Inc. (Nasdaq:NVAX) is a
clinical-stage vaccine company committed to delivering novel
products to prevent a broad range of infectious diseases. Our
recombinant nanoparticles and Matrix-M(TM) adjuvant technology are
the foundation for groundbreaking innovation that improves global
health through safe and effective vaccines. Additional information
about Novavax is available on the Company's
website, novavax.com.
References
1. A.R. Falsey et al.
Respiratory syncytial virus infection in elderly and high-risk
adults. N Engl J Med. 2005; 352:1749-59.
2. A.R. Falsey et al.
Respiratory syncytial virus and influenza A infections in the
hospitalized elderly. J. Infect Dis. 1995; 172:389-94.
3. W.W. Thompson et al. Mortality associated with
influenza and respiratory syncytial virus in the United States.
JAMA 2003; 289(2): 179-186.
4. K. Widmer et al. Rates of
hospitalizations for respiratory syncytial virus, human
metapneumovirus, and influenza virus in older adults. J Infect Dis.
2012; 206: 56-62.
5. K. Widmer et al. Respiratory
syncytial virus & human metapneumovirus-associated emergency
department and hospital burden in adults. Influenza and Other
Respiratory Viruses. 2014; 8(3): 347-352.
Forward-Looking Statements
Statements herein relating to the
future of Novavax and the ongoing development of its vaccine and
adjuvant products are forward-looking statements. Novavax cautions
that these forward looking statements are subject to numerous risks
and uncertainties, which could cause actual results to differ
materially from those expressed or implied by such statements.
These risks and uncertainties include those identified under the
heading "Risk Factors" in the Novavax Annual Report on Form 10-K
for the year ended December 31, 2015, and our Quarterly Reports on
Form 10-Q for the quarters ended June 30, 2016 and September 30,
2016, filed with the Securities and Exchange Commission (SEC). We
caution investors not to place considerable reliance on the
forward-looking statements contained in this press release. You are
encouraged to read our filings with the SEC, available at sec.gov,
for a discussion of these and other risks and uncertainties. The
forward-looking statements in this press release speak only as of
the date of this document, and we undertake no obligation to update
or revise any of the statements. Our business is subject to
substantial risks and uncertainties, including those referenced
above. Investors, potential investors, and others should give
careful consideration to these risks and uncertainties.
Contact:
Investor Relations
Novavax, Inc.
Andrea N. Flynn, Ph.D.
Associate Director, Investor Relations
ir@novavax.com
240-268-2000
Westwicke Partners
John Woolford
john.woolford@westwicke.com
443-213-0506
Media
Russo Partners, LLC
David Schull
david.schull@russopartnersllc.com
212-845-4271
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Novavax, Inc. via Globenewswire
Novavax (NASDAQ:NVAX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Novavax (NASDAQ:NVAX)
Historical Stock Chart
From Apr 2023 to Apr 2024