Novavax Initiates Pivotal Phase 3 Trial of the RSV F Vaccine in Older Adults
09 November 2015 - 10:55PM
GAITHERSBURG, Md., Nov. 09, 2015
(GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX), a clinical-stage
vaccine company focused on the discovery, development and
commercialization of recombinant nanoparticle vaccines and
adjuvants, today announced the initiation of a Phase 3 clinical
trial, known as Resolve(TM), of its respiratory syncytial virus
F-protein nanoparticle vaccine candidate (RSV F Vaccine) in older
adults (60 years of age and older).
The Resolve trial is a randomized,
observer-blinded, placebo-controlled trial designed to enroll up to
11,850 older adults at 60 sites in the United States. Participants
are being enrolled and vaccinated in advance of the 2015-16 RSV
season, with top-line results expected in the second half of
2016.
The primary efficacy objective of
the Resolve trial is the prevention of moderate-severe
RSV-associated lower respiratory tract disease, as defined by the
presence of multiple lower respiratory tract symptoms. The trial's
objectives, endpoints and statistical approach were finalized based
on the FDA's recommendations during the recent End of Phase 2
meeting. The results of a Phase 2 trial in older adults, reported
by Novavax in August 2015, provided the basis for the Phase 3 trial
design, including the determination of the attack rate, vaccine
efficacy and case definitions.
"We have taken advice and
recommendations from the FDA, along with numerous key opinion
leaders and clinical experts, to design the Resolve trial to align
with and build on the strength of our previous clinical results,"
said Stanley C. Erck, President and CEO. "The primary objective of
this clinical trial captures moderate-severe RSV disease that
drives an estimated annual economic burden of more than $24 billion
in the United States alone. The Resolve trial takes Novavax one
step closer to bringing this important vaccine to licensure, years
ahead of other RSV vaccine development efforts."
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.1,2The U.S.
Centers for Disease Control and Prevention (CDC) reports that each
year the disease causes 177,000 hospitalizations and 14,000 deaths
among adults older than 65.3 Annually,
there are approximately 900,000 medical interventions directly
caused by RSV disease.4,5 Currently,
there is no approved RSV vaccine available.
About 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:
- Falsey, A.R. et al. Respiratory syncytial
virus infection in elderly and high-risk adults. N Engl J Med, 2005; 352:1749-59;
extrapolated to 2015 census population.
- Falsey, A.R. et al. Respiratory Syncytial
Virus and Influenza A Infections In The Hospital
Elderly. J. Infect
Dis,1995;172:389-94
-
CDC: http://www.cdc.gov/rsv/research/us-surveillance.html
- Widmer, K. et al. Rates of
Hospitalizations for Respiratory Syncytial Virus, Human
Metapneumovirus and Influenza Virus in Older
Adults. J Infect
Dis, 2012; 206: 56-62.
- Widmer, K. et al. Respiratory
Syncytial Virus & Human Metapneumovirus-Associated Emergency
Department and Hospital Burden in Adults. Influenza Other Respir
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, 2014, and our Quarterly Reports on
Form 10-Q for the quarters ended March 31, 2015 and June 30, 2015,
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:
Novavax, Inc.
Barclay A. Phillips
SVP, Chief Financial Officer and Treasurer
Andrea N. Flynn, Ph.D.
Senior Manager, Investor Relations
ir@novavax.com
240-268-2000
Russo Partners, LLC
David Schull
Todd Davenport, Ph.D.
david.schull@russopartnersllc.com
todd.davenport@russopartnersllc.com
212-845-4271
This
announcement is distributed by NASDAQ OMX Corporate Solutions on
behalf of NASDAQ OMX 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
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