DGAP-News: Novavax Initiates Dose-Confirmatory Phase 2 Clinical Trial of its RSV Vaccine Candidate
(firmenpresse) - Novavax, Inc.
07.10.2013 22:38
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ROCKVILLE, Md., 2013-10-07 22:38 CEST (GLOBE NEWSWIRE) --
Novavax, Inc. (Nasdaq:NVAX) today announced that enrollment has begun in a
Phase 2 dose-confirmatory clinical trial of its respiratory syncytial virus
(RSV) vaccine candidate in women of childbearing age.
This randomized, blinded, placebo-controlled Phase 2 study will evaluate the
immunogenicity and safety of multiple formulations of Novavax' RSV-F protein
nanoparticle vaccine candidate with aluminum phosphate as an adjuvant. The
study is scheduled to enroll 720 women of childbearing age who will receive
either one or two intramuscular injections at each dose level of vaccine or
placebo at days 0 and 28. Immunogenicity and safety will be evaluated over
three month and six month periods, respectively.
'This trial represents important progress for our RSV vaccine, which is being
developed to protect young infants through maternal immunization,' said Gregory
Glenn M.D., Senior Vice President and Chief Medical Officer of Novavax. 'This
study will help define the dose and dose regimen and expand the safety database
for our maternal immunization strategy. These are all essential steps in the
advancement of this important vaccine towards licensure.'
About RSV
RSV is a respiratory pathogen that afflicts all humans regardless of age. In
healthy adults, RSV infections are generally mild to moderate in severity, but
may be more severe in infants and young children as well as the elderly and
adults with underlying chronic cardiac or pulmonary disease. Globally, RSV is a
common cause of childhood respiratory infection, with a disease burden of 64
million cases and approximately 160,000 deaths annually. Severe RSV disease
results in 3.4 million hospital admissions per year globally and
disproportionately affects infants below six months of age. It is estimated
that between 11,000 to 17,000 elderly and high risk adults die of RSV infection
annually in the U.S., with up to 180,000 hospitalizations for serious
respiratory symptoms. Currently, there is no approved RSV prophylactic vaccine
available for either of these populations.
About Novavax
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company
creating novel vaccines and vaccine adjuvants to address a broad range of
infectious diseases worldwide. Using innovative proprietary recombinant protein
nanoparticle vaccine technology, the company produces vaccine candidates to
efficiently and effectively respond to both known and newly emergent diseases.
Additional information about Novavax is available on the company's website,
novavax.com.
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, 2012,and Form 10-Q for the
period ended June 30, 2013, both 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: Barclay A. Phillips
SVP, Chief Financial Officer and Treasurer
Novavax, Inc.
240-268-2000
News Source: NASDAQ OMX
07.10.2013 Dissemination of a Corporate News, transmitted by DGAP -
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Language: English
Company: Novavax, Inc.
United States
Phone:
Fax:
E-mail:
Internet:
ISIN: US6700021040
WKN:
End of Announcement DGAP News-Service
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Datum: 07.10.2013 - 22:38 Uhr
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