Novavax Initiates Global Pivotal Phase 3 Trial of the RSV F Vaccine to Protect Infants via Maternal Immunization
(Thomson Reuters ONE) -
GAITHERSBURG, Md., Dec. 03, 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 enrollment of the first participant in a global
pivotal Phase 3 clinical trial, known as Prepare(TM), of its respiratory
syncytial virus F-protein nanoparticle vaccine candidate (RSV F Vaccine) in
healthy pregnant women.
The Prepare trial is a randomized, observer-blinded, placebo-controlled trial
that utilizes a group sequential design, offering flexibility in trial size that
is responsive to the rate of endpoint events and evolving evidence of efficacy
while maintaining the trial's blinding integrity. Thus, the eventual sample size
may vary between 5,000 and 8,255 pregnant women over a period of two to four
years. Participants are being vaccinated at a number of global clinical sites in
advance of each region's RSV season. Novavax previously announced it was awarded
a grant up to $89 million from the Bill & Melinda Gates Foundation to support
development of this RSV F Vaccine Phase 3 clinical trial in pregnant women.
The primary objective of the Prepare trial is to determine the efficacy of
maternal immunization with the RSV F Vaccine against symptomatic RSV lower
respiratory tract infection (LRTI) with hypoxemia in infants through the first
90 days of life. The trial's objectives, endpoints and statistical approach were
finalized following a recent End of Phase 2 meeting with the FDA. The results of
a Phase 2 trial in pregnant women, as reported by Novavax in September 2015,
provided the basis for the Phase 3 trial design, including the determination of
anti-RSV antibody responses in mothers and antibody transfer from mothers to
infants.
"We believe that maternal immunization offers the optimal way of protecting
young infants, who are among the most susceptible populations to RSV disease.
Initiation of this trial builds on our groundbreaking Phase 2 clinical data in
this important population, and incorporates discussions with experts in the
field and the FDA," said Stanley C. Erck, President and CEO. "The initiation of
our second pivotal Phase 3 trial this quarter, ahead of our guidance,
demonstrates the ability of our team to execute along aggressive timelines."
A fact sheet on maternal immunization is available
at: http://novavax.com/download/files/pipeline/151_Novavax_FactSheet_FIN_D_9x10.
pdf
About RSV
Respiratory syncytial virus (RSV) is the most common cause of lower respiratory
tract infections and the leading viral cause of severe lower respiratory tract
disease in infants and young children worldwide, with estimated annual infection
and mortality rates of 64 million and 160,000, respectively.1 In the US, RSV is
the leading cause of hospitalization of infants, and globally, is second only to
malaria as a cause of death in children under 1 year of age.2,3 Despite the
induction of post-infection immunity, repeat infection and lifelong
susceptibility to RSV is common.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. Nair, H. et al. Global burden of acute lower respiratory infections due to
respiratory syncytial virus in young children: a systematic review and meta-
analysis. Lancet, 2010; 375: 1545-1555.
2. Hall, C.B. et al. Respiratory Syncytial Virus-Associated hospitalizations
Among Children Less Than 24 Months of Age. Pediatrics, 2013; 132(2): E341-
348.
3. Oxford Vaccine Group: http://www.ovg.ox.ac.uk/rsv
4. Glezen, W.P. et al. Risk of primary infection and reinfection with
respiratory syncytial virus. Am J Dis Child, 1986; 140:543-546.
5. Glenn GM, et al. Modeling maternal fetal RSV F vaccine induced antibody
transfer in guinea pigs. Vaccine, 2015; In press.
http://dx.doi.org/10.1016/j.vaccine.2015.08.039.
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
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(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
[HUG#1971354]
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Datum: 03.12.2015 - 22:05 Uhr
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News-ID 437562
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