Novavax Initiates Pivotal Phase 3 Trial of the RSV F Vaccine in Older Adults
(Thomson Reuters ONE) -
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.(1,2)The 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:
1. 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.
2. Falsey, A.R. et al. Respiratory Syncytial Virus and Influenza A Infections
In The Hospital Elderly. J. Infect Dis,1995;172:389-94
3. CDC: http://www.cdc.gov/rsv/research/us-surveillance.html
4. 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.
5. 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(at)novavax.com
240-268-2000
Russo Partners, LLC
David Schull
Todd Davenport, Ph.D.
david.schull(at)russopartnersllc.com
todd.davenport(at)russopartnersllc.com
212-845-4271
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Novavax, Inc. via GlobeNewswire
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Datum: 09.11.2015 - 12:55 Uhr
Sprache: Deutsch
News-ID 433018
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