Novavax Initiates Phase 1/2 Trial of NanoFlu(TM) Vaccine in Older Adults
(Thomson Reuters ONE) -
* Recently published NanoFlu(TM) preclinical data provide strong rationale for
Phase 1/2 clinical trial based on robust antibody titers and improved
protective responses against both current and drifted strains
* Data from trial expected by the end of 2017
GAITHERSBURG, Md., Sept. 19, 2017 (GLOBE NEWSWIRE) -- Novavax, Inc.,
(Nasdaq:NVAX) today announced the enrollment of the first participant in a Phase
1/2 clinical trial of its nanoparticle influenza vaccine candidate including its
proprietary Matrix-M(TM) adjuvant (NanoFlu(TM)) in older adults.
The trial is a randomized, observer-blinded, active comparator-controlled trial
in approximately 330 healthy older adults. The primary objective of the trial is
to assess the safety and immunogenicity of two concentrations (15 µg or 60 µg)
of NanoFlu compared to a licensed influenza vaccine, Fluzone® High-Dose (Fluzone
HD).
"The trial is designed to identify an immune response, characterized by
hemagglutination-inhibiting (HAI) and neutralizing antibodies, that is similar
to or better than Fluzone HD," said Gregory Glenn, M.D., President of Research
and Development. "We will evaluate immunogenicity using HAI titers, which are
the industry standard and an established surrogate marker of protection. Data
from this trial may provide the basis to request accelerated approval for
initial licensure of our NanoFlu vaccine.
"Our recent preclinical data further indicate NanoFlu elicits improved
protective responses against drifted strains, which could be a key
differentiating factor of the vaccine. Current influenza vaccine protection is
typically limited to strain-specific immune responses. Strain mismatch or
antigenic drift between seasonal vaccines and circulating influenza strains can
lead to reduced protection."
"The data described in our recent Vaccine publication provided strong rationale
for advancing our NanoFlu program into the clinic," said Stanley C. Erck,
President and CEO. "Seasonal influenza remains a significant threat to older
adults, with nearly three million infections and over 250,000 hospitalizations
annually(1). Our goal is to deliver a differentiated flu vaccine to the greater
than $3 billion global seasonal influenza commercial market(2) and we look
forward to delivering clinical data from this trial by the end of the year."
About Accelerated Approval
Accelerated approval may be granted for certain biological products that have
been studied for their safety and effectiveness in treating serious or life-
threatening illnesses and that provide meaningful therapeutic benefit over
existing treatments.
Such an approval will be based on adequate and well-controlled clinical trials
establishing that the biological product has an effect on a surrogate endpoint
that is reasonably likely, based on epidemiologic, therapeutic,
pathophysiologic, or other evidence, to predict clinical benefit. More
information on accelerated approval can be found
here: https://www.fda.gov/biologicsbloodvaccines/guidancecomplianceregulatoryinf
ormation/guidances/vaccines/ucm074794.htm
About Novavax
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biotechnology 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. Average of 3 past seasons, 2010-2013; includes vaccine averted cases. C. Reed
et al. Estimating Influenza Disease Burden from Population-Based Surveillance
Data in the United States. PLOS One. 2015, DOI:10.1371/journal.pone.0118369
2. PharmaPoint Seasonal Influenza Vaccines Global Drug Forecast and Market
Analysis to 2025, October 2016
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, 2016 and the Report on Form 10-Q
for the period ended June 30, 2017, both as 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:
Investor Relations
Novavax, Inc.
Andrea N. Flynn, Ph.D.
Director, Investor & Media Relations
ir(at)novavax.com
240-268-2000
Westwicke Partners
John Woolford
john.woolford(at)westwicke.com
443-213-0506
Media
Russo Partners, LLC
David Schull
Maggie Beller
david.schull(at)russopartnersllc.com
maggie.beller(at)russopartnersllc.com
212-845-4271
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq 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
Unternehmensinformation / Kurzprofil:
Datum: 19.09.2017 - 15:05 Uhr
Sprache: Deutsch
News-ID 560458
Anzahl Zeichen: 6641
contact information:
Town:
Maryland
Kategorie:
Business News
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