Novavax's Seasonal Influenza VLP Vaccine Candidate Shows Positive Results in a Phase II Clinical Trial in Older Adults
-- Both 15 and 60 mcg doses well-tolerated and immunogenic in older adults 60 years or higher in age -- Preliminary evidence shows improved immunogenicity at higher VLP dose
ROCKVILLE, Md., April 29 /PRNewswire-FirstCall/ -- Novavax, Inc.
(NASDAQ:
NVAX) reported today that its trivalent seasonal influenza
virus-like-particle (VLP)-based vaccine candidate was safe and
immunogenic against the 2009-2010 seasonal influenza virus strains
in older adults 60 years or higher in age.
In a double-blind, active-controlled Phase II study of 480
randomized subjects, the safety, tolerability and immunogenicity of
a single 15 microgram dose or 60 microgram dose (per strain) of
trivalent influenza VLP was compared to a dose of a commercially
available inactivated trivalent influenza vaccine (TIV). The
primary immunogenicity measure in the study was hemagglutination
inhibition (HAI) antibody response induced by the vaccine 21 days
after immunization. At both the high (60 microgram) and low (15
microgram) dose, the VLP vaccine showed no significant increase in
severe local or systemic adverse events.
While the study was not powered to obtain definitive differences
in immunogenicity between VLP doses or establish non-inferiority
between VLPs and TIV, a preliminary analysis of immunogenicity
results showed that the 60 microgram dose of trivalent VLP vaccine
induced a statistically significant higher seroconversion rate than
TIV against one of the three 2009-2010 strains of seasonal
influenza virus and showed no statistically significant difference
from TIV in the seroconversion rate against the other two strains.
The 15 microgram dose of trivalent VLP vaccine did not induce
significantly different seroconversion rates than TIV for two of
the three strains, but induced a significantly lower seroconversion
rate compared to TIV against one of the strains.
These immunogenicity responses observed in the VLP vaccine
groups will be used to guide the selection of a dose most likely to
meet or exceed the U.S. and European regulatory guidelines for
immunogenicity and safety criteria for licensure of the vaccine for
older adults.
Dr. Rahul Singhvi, President and CEO of Novavax, stated: "We are
pleased to see that both doses of VLP vaccine were well tolerated
and immunogenic in older adults, which was a key question for this
trial. The finding that a higher dose of VLP vaccine could be more
immunogenic in this population is particularly important since
there is a significant medical need for a better vaccine for older
adults. These data show that our recombinant, VLP-vaccine
technology affords great flexibility in using dose as a means to
improve the possible effectiveness of the vaccine. The data from
this clinical trial and from our recent Phase II influenza vaccine
study in healthy younger adults suggest that our trivalent
influenza vaccine may be effective in a broad range of subjects.
Taken together, the findings from these studies are encouraging and
will be useful for planning further clinical testing of our
trivalent VLP influenza vaccine."
About VLPs
Virus-like particles (VLPs) mimic the external structure of
viruses but lack the live genetic material that causes viral
replication and infection. VLPs can be designed quickly to match
individual viral strains and be produced efficiently using portable
cell-culture technology. Novavax's VLP-based vaccine candidates are
produced more rapidly than egg-based vaccines by using proprietary,
portable, recombinant cell-culture technology.
About Novavax
Novavax, Inc. is a clinical-stage biopharmaceutical company
creating novel vaccines to address a broad range of infectious
diseases worldwide, including H1N1, using advanced proprietary
virus-like-particle (VLP) technology. The company produces potent
VLP-based, recombinant vaccines utilizing new and efficient
manufacturing approaches. Novavax is committed to using its VLP
technology to create country-specific vaccine solutions. In 2009,
Novavax launched a joint venture with Cadila Pharmaceuticals, named
CPL Biologicals, to develop and manufacture vaccines, biological
therapeutics and diagnostics in India. Additional information about
Novavax is available on the company's website:
www.novavax.com.
Forward-Looking Statements
Statements herein relating to future performance, conditions or
strategies and other matters, including expectations regarding
clinical trials, release of new data, continued development of the
seasonal vaccine and its potential differentiation, are
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act. Novavax cautions that these
forward-looking statements are subject to numerous assumptions,
risks and uncertainties, which change over time. Factors that may
cause actual results to differ materially from the results
discussed in the forward-looking statements or historical
experience include historical and current results that may not be
predictive of future trial results for the seasonal vaccine or any
other vaccine that we are developing or may develop; further
testing is required before regulatory approval can be applied for
and the FDA may not approve a vaccine even if the results are
similar or better than the results reported to date; uncertainties
related to the initiation, enrollment, progress and completion of
clinical trials; safety or efficacy issues not seen to date may be
encountered; the immune systems of the elderly pose significant
challenges for vaccines and our products may not be as efficacious
in the elderly as they have been in test subjects to date; the
company has not yet manufactured, or relied on third parties to
manufacture, any vaccines at a commercial scale; and the seasonal
influenza vaccine industry is intensely competitive, making it
difficult for our vaccine to have market success even if approved.
Further information on the factors and risks that could affect
Novavax's business, financial conditions and results of operations,
is contained in Novavax's filings with the U.S. Securities and
Exchange Commission, which are available at www.sec.gov. These
forward-looking statements speak only as of the date of this press
release, and Novavax assumes no duty to update forward-looking
statements.
Source: Novavax, Inc.
CONTACT: Fred Driscoll, Chief Financial Officer, Novavax,
Inc.,
+1-240-268-2000
Web Site: http://www.novavax.com/
Posted: April 2010
