Novavax Initiates Phase 2 Safety and Immunogenicity Trial of the RSV F Vaccine in Older Adults
January 19 2017 - 4:05PM
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™ 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™ 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™
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™ 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
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