Du är här

2015-09-10

Novavax, Inc.: Novavax RSV F Vaccine Clinical Trial Data in Women of Child Bearing Age Published in the Journal of Infectious Disease

GAITHERSBURG, Md., Sept. 10, 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 that the full data set from its clinical trial of the RSV F-protein recombinant nanoparticle vaccine candidate (RSV F Vaccine) in women of childbearing age (18-35 years) were published in theJournal of Infectious Disease
. The Company previously announcedtop-line resultsfrom the trial.
The manuscript describes the randomized, blinded, placebo-controlled Phase 2
clinical trial that evaluated the safety and immunogenicity of two dose
levels of the RSV F Vaccine with and without aluminum phosphate adjuvant. The
trial enrolled 330 women of childbearing age who received either one or two
intramuscular injections of a single-dose (60 or 90 µg) of vaccine or placebo
at study days 0 and 28.

The manuscript details the significant antibody response to the RSV F Vaccine
including a 6.5-15.6-fold increase in anti-F IgG antibodies across all
vaccine doses at day 56, with significantly higher levels in the two-dose
adjuvanted regimens. Palivizumab-competing antibody (PCA) levels were
undetectable at day 0 but increased up to between 205-325 µg/mL at day 56.
Further, a 2.7 and 3.5-fold rise in RSV/A and RSV/B microneutralizing
antibodies were detected at day 56, prior to the RSV season. Finally, between
days 56 and 112, 21% (12/56) of placebo recipients showed evidence of a
recent RSV infection by Western Blot compared to 11% of vaccinees (26/244) (p
= 0.04).

"These data are the foundation for our ongoing RSV F Vaccine development
program to protect infants via maternal immunization," said Gregory Glenn,
M.D., Senior Vice President of Research and Development. "The RSV F Vaccine
stimulated high levels of anti-F, PCA and microneutralizing antibodies.
Further, ourad hoc
analysis via Western Blot, together with our recent data in older adults,
provides an additional indication that the vaccine-induced immunity can
protect against RSV infections in humans. We look forward to announcing
additional data from our trial of the RSV F Vaccine in pregnant women later
this quarter, a key milestone in our strategy to develop a vaccine designed
to protect infants via maternal immunization."

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,
respectively1. In the US, RSV is responsible for approximately 57,000
hospitalizations of children under five years of age annually, the vast
majority of which occur in infants less than one year old, and especially
those under six months of age2-4. Despite the induction of post-infectious
immunity, repeat infection and lifelong susceptibility is common5. Currently,
there is no approved RSV vaccine available. Palivizumab is a monoclonal
antibody, licensed and sold by MedImmune as Synagis®, that targets the RSV F
protein and is used for prophylaxis against RSV disease in high risk infants.

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. Stockman, L.J.et al.
Respiratory syncytial virus-associated hospitalizations among infants and
young children in the United States, 1997-2006.Pediatr Infect Dis J
, 2012; 31:5-9.

3. Centers for Disease Control and Prevention, update May 5, 2015. Respiratory
Syncytial Virus Infection. Trends and
Surveillance.http://www.cdc.gov/rsv/research/us-surveillance.html

4. Boyce, T.G.et al.
Rates of hospitalization for respiratory syncytial virus infection among
children in Medicaid.J Pediatr
, 2000; 137:865-870.

5. Glezen, W.P.et al.
Risk of primary infection and reinfection with respiratory syncytial virus.Am
J Dis Child
, 1986; 140:543-546.

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, 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

HUG#1951219

Författare Hugin

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.