Novavax Presents RSV F Protein Nanoparticle Vaccine Clinical Data at the 8th Vaccine & ISV Congress in Philadelphia on Sunday, October 26
(Thomson Reuters ONE) -
GAITHERSBURG, Md., Oct. 26, 2014 (GLOBE NEWSWIRE) -- Novavax, Inc.
(Nasdaq:NVAX), a clinical-stage biopharmaceutical company focused on the
discovery, development and commercialization of recombinant nanoparticle
vaccines and adjuvants, announced today that Gregory Glenn, M.D., SVP, Research
and Development is presenting new immunogenicity data from Novavax' RSV F-
Protein Nanoparticle vaccine candidate (RSV F vaccine) clinical trials at the
8(th) Vaccine & ISV Congress in Philadelphia, PA.
Dr. Glenn's presentation titled: Immunogenicity of the RSV nanoparticle vaccine
in humans and the induction of palivizumab competing antibodies, highlights new
data from the company's first Phase 2 clinical trial in 330 women of
childbearing age. In all participants (including placebo recipients), sera were
evaluated using Western Blot for evidence of new infection at day 0, 56 and
115. All vaccinations were complete by day 56 and from day 56 to 112, subjects
passed through what approximates an RSV season, December to March. During this
period, 20% of the placebo recipients had evidence of a new RSV infection
compared to only 10% of the immunized participants, representing a 50% reduction
in infection rates. Prevention of RSV infection in women of childbearing age
suggests that the vaccine, which is expected to provide benefit to newborns,
pediatrics and elderly, could also benefit pregnant women. The potential to
protect pregnant women from RSV infection would be consistent with
recommendations to vaccinate pregnant women against seasonal influenza and
provide additional benefit to a maternal immunization program.
"Prevention of infection is a high bar relative to preventing respiratory
disease. The data presented today suggest that our RSV F vaccine reduced the
incidence of RSV infection by 50%. These findings are in line with preclinical
cotton rat studies showing that the RSV F vaccine was effective in preventing
both lung disease and nasal infection in challenge studies, which were recently
published in the Journal Vaccine," said Gregory Glenn, M.D., SVP, Research and
Development at Novavax. "These new clinical data, along with the cotton rat
model, continue to build our confidence in the potential efficacy of our vaccine
and our plan to initiate three RSV clinical trials, for maternal immunization,
pediatrics and the elderly in the third and fourth quarter of this year."
About RSV
RSV is a widespread disease that causes infections of the lower respiratory
tract. While RSV affects individuals of all ages, it acutely impacts infants,
the elderly, young children and others with compromised immune systems. RSV is
the number one cause of hospitalization in infants ages 0 to 12 months in the
U.S. and is a significant cause of infant morbidity and mortality globally.
Current estimates indicate that RSV is responsible for over 30 million new acute
lower respiratory infection episodes and between 150,000 and 200,000 deaths in
children under five years old. In the U.S., nearly all children become infected
with RSV before they are two years old; it has been associated with 20% of
hospitalizations and 15% of office visits for acute respiratory infection in
young children. The World Health Organization (WHO) estimates that the global
disease burden for RSV is 64 million cases. Because there is no approved
prophylactic vaccine, an RSV vaccine has the potential to protect millions of
patients from this far-reaching unmet medical need.
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
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.
Novavax 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, 2013, 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
David Schull or Andrea Flynn, Ph.D.
Russo Partners, LLC
212-845-4271
David.schull(at)russopartnersllc.com
Andrea.flynn(at)russopartnersllc.com
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
[HUG#1865886]
Unternehmensinformation / Kurzprofil:
Datum: 26.10.2014 - 15:10 Uhr
Sprache: Deutsch
News-ID 346933
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"Novavax Presents RSV F Protein Nanoparticle Vaccine Clinical Data at the 8th Vaccine & ISV Congress in Philadelphia on Sunday, October 26"
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