Novavax Initiates Phase 2 Safety and Immunogenicity Trial of the RSV F Vaccine in Older Adults
(Thomson Reuters ONE) -
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(at)novavax.com
240-268-2000
Westwicke Partners
John Woolford
john.woolford(at)westwicke.com
443-213-0506
Media
Russo Partners, LLC
David Schull
david.schull(at)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
Unternehmensinformation / Kurzprofil:
Datum: 19.01.2017 - 22:05 Uhr
Sprache: Deutsch
News-ID 518850
Anzahl Zeichen: 6700
contact information:
Town:
Maryland
Kategorie:
Business News
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"Novavax Initiates Phase 2 Safety and Immunogenicity Trial of the RSV F Vaccine in Older Adults"
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