NOVAVAX Presents Positive Clinical Results at The World Health Organization Conference, Geneva, Switzerland
- Positive Clinical Results from Pivotal Study of H1N1 Virus-Like Particle (VLP) Pandemic Influenza Vaccine in Mexico - Immunogenicity responses at all dose levels meet U.S. and European regulatory authorities recommended criteria for seroconversion and seroprotection - More than fifty percent of the volunteers already enrolled in Stage B of study
ROCKVILLE, Md., Feb. 19 /PRNewswire-FirstCall/ -- Novavax, Inc.
(NASDAQ: NVAX) today presented to the world's
leading pandemic influenza vaccine experts a summary of the recent
preliminary safety and immunogenicity data from its Pivotal 2009
A/H1N1 VLP pandemic influenza vaccine study in Mexico. The
presentation of the results were made by Maria Allende, M.D., at
the invitation-only 6th World Health Organization (WHO) Meeting on
Evaluation of Pandemic Influenza Vaccines in Clinical Trials, held
at the WHO headquarters in Geneva, Switzerland. The presentation is
available at www.novavax.com under the Investors/Events tab.
In this study, 1,000 healthy volunteers aged 18 to 64 years old
were enrolled to receive two doses of 5 mcg, 15 mcg or 45 mcg of
Novavax's 2009 H1N1 influenza VLP or a placebo to determine the
safety and immunogenicity of the vaccine. Preliminary results at
Day 14 after a single dose of Novavax's 2009 H1N1 VLP pandemic
influenza vaccine from approximately 500 subjects showed that the
vaccine was well tolerated at all three dose levels and exhibited
no systemic side effects and mostly mild local site reactions,
similar to placebo. After only one dose of either 5 mcg, 15 mcg or
45 mcg in these volunteers, the vaccine achieved robust serological
immune responses that are considered protective. These preliminary
data indicate that a single dose of 15 mcg appears to be optimal to
induce robust immune responses in broader age populations with a
highly satisfactory safety profile. This dose has been selected for
continuation into the second stage or Stage B of this trial.
The trial's Stage B of testing, which will enroll approximately
3,000 subjects, is currently ongoing and more than fifty percent of
the subjects have now been enrolled in this expanded safety phase.
Subjects enrolled in this stage of the study receive a single dose
of 15 mcg of Novavax's 2009 H1N1 VLP pandemic vaccine. Currently,
an independent Data and Safety Monitoring Board (DSMB) is reviewing
the safety and immunogenicity data from all 1,000 subjects of Stage
A of the study and will provide an update in the near future.
Dr. Rahul Singhvi, President and Chief Executive Officer of
Novavax, stated: "The data presented today suggest that our H1N1
VLP vaccine is well tolerated and has a robust immune response even
at a low dose of 5 mcg. This is remarkable given that our vaccine
does not contain any adjuvant. Stage B enrollment of 3,000
subjects, which is more than fifty percent complete, coupled with
subjects previously enrolled in Stage A of this trial and other
clinical trials should provide us with a sizeable database of
safety information that is key to progressing our vaccine to
ultimate regulatory approval and commercialization
worldwide."
About Novavax
Novavax, Inc. is a clinical-stage biotechnology 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. The
company has formed 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 Statement
Statements herein relating to clinical trials and development of
the 2009 H1N1 and seasonal vaccines, the potential use of any data
from clinical trials in Mexico and other countries, including the
U.S., are forward-looking statements within the meaning of the
Private Securities Litigation Reform Act. 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 include full and complete
clinical trial results, which may not be sufficient for regulatory
approval in Mexico or may indicate safety concerns not yet
encountered; even if the results reported today or other final and
complete results of the clinical trial are positive, the data may
not be accepted by regulatory bodies in the U.S. or other
countries; the 2009 H1N1 vaccine may not be approved by the Mexican
government or additional clinical trials may be required; even if
approved by the Mexican government, sales of the 2009 H1N1 vaccine
may be poor because there is currently an over supply of H1N1
vaccine; our vaccines have not been manufactured at commercial
levels and unanticipated costs and delays during the scale-up
process could occur; and the 2009 H1N1 vaccine must be manufactured
quickly, or it may not be available for sale in Mexico until after
the 2009/2010 flu season has ended even if approved. Further
information on 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: Tricia J. Richardson, Novavax, Inc.,
+1-240-268-2031
Web Site: http://www.novavax.com/
Posted: February 2010
