Novavax Initiates Phase 2 Clinical Trial of RSV Vaccine in Elderly Subjects
(Thomson Reuters ONE) -
GAITHERSBURG, Md., Oct. 14, 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, today announced that enrollment has begun in a Phase 2
clinical trial of its respiratory syncytial virus (RSV) F-protein nanoparticle
vaccine candidate (RSV F Vaccine), in healthy elderly subjects.
The trial is a randomized, observer-blinded, placebo-controlled Phase 2 study
scheduled to enroll 1,600 elderly subjects (>60 years of age) at ten sites in
the United States. The trial will evaluate the incidence of all respiratory
illnesses due to RSV, including medically-attended respiratory illnesses due to
RSV, and hospitalizations for respiratory illness due to RSV in community-living
elderly adults who have been treated with placebo. The study will also evaluate
the safety and immunogenicity of a 135µg dose of the RSV F Vaccine compared with
placebo. The trial will also estimate the efficacy of the RSV F Vaccine in
reducing the incidence of respiratory illnesses due to RSV.
"The initiation of this elderly clinical trial, shortly after the initiation of
our Phase 2 maternal immunization trial last month, demonstrates our commitment
to the strategy of building an RSV franchise. The goal of that strategy is to
maximize the value of this product candidate for susceptible populations, the
medical community, and our shareholders," said Stanley C. Erck, President and
CEO of Novavax, Inc. "Today there is a significant unmet medical need for an RSV
vaccine for the approximately 57 million individuals over the age of 60 in the
US. This suggests that the elderly market may be the largest value driver in our
RSV franchise."
"RSV is increasingly recognized by the medical and scientific community as a
pathogen of great importance in the elderly population. This key study will
evaluate RSV respiratory illness incidence rates in the elderly population in a
prospective manner, further develop our safety and immunogenicity database in
older adults and provide an estimate of the RSV F Vaccine's efficacy. Answers to
these questions will inform the design of our projected Phase 3 pivotal study,"
said Greg Glenn, SVP, Research and Development at Novavax, Inc. "It is our goal
to commence three RSV clinical trials in the fourth quarter, furthering the
development of our RSV F Vaccine in each of the three key target populations:
young infants via maternal immunization, children beyond infancy, and the
elderly. We look forward to initiation of our Phase 1 Pediatric RSV study later
this quarter."
About RSV
RSV is a major respiratory pathogen with a significant burden of disease in the
very young and in the elderly. 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 or its complications annually in the U.S., and up to
180,000 are hospitalized for serious respiratory symptoms. Currently, there is
no approved RSV vaccine available for any 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, 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
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#1862705]
Unternehmensinformation / Kurzprofil:
Datum: 14.10.2014 - 14:36 Uhr
Sprache: Deutsch
News-ID 343849
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