NOVAVAX Announces Positive Clinical Results from First Stage of Pivotal Study of 2009 A/H1N1 VLP Pandemic Influenza Vaccine in Mexico
-- Independent Data Safety Monitoring Board (DSMB) concludes that Novavax's 2009 H1N1 VLP pandemic influenza vaccine is well-tolerated and induces robust immune responses with a single injection at all dose levels tested -- Stage B enrollment completed with over 3,500 volunteers in the trial
ROCKVILLE, Md., March 24 /PRNewswire-FirstCall/ -- Novavax, Inc.
(NASDAQ: NVAX) announced today positive results
from the entire 1,000 subject Stage A of its two-stage pivotal
study evaluating the safety and immunogenicity of Novavax's
unadjuvanted 2009 A/H1N1 virus-like particle (VLP) pandemic
influenza vaccine. The data showed that safety and immunogenicity
of the vaccine were consistent with preliminary results disclosed
earlier from the first 500 volunteers of Stage A where the vaccine
was found to be well tolerated and immunogenic at all three dose
levels tested. Novavax is conducting this study in collaboration
with Avimex Laboratories of Mexico to support registration of the
vaccine in Mexico and potentially other countries. The study is
being conducted at the Mexican Institute of Social Security (IMSS),
which is the largest medical and research center in Latin
America.
The Stage A part of the pivotal trial is a randomized,
double-blind, placebo-controlled study in which 1,000 healthy
volunteers aged 18 to 64 years old were evaluated to determine the
safety, tolerability and immunogenicity of the vaccine. All
volunteers were vaccinated with two doses of either 5 mcg, 15 mcg
or 45 mcg of Novavax's 2009 A/H1N1 VLP pandemic influenza vaccine
or a placebo. The DSMB reviewed the safety and immunogenicity data
from 1,000 healthy volunteers. Serological results from the 1,000
subjects 14 days after the first injection of Novavax's 2009 A/H1N1
VLP pandemic influenza vaccine showed that the vaccine at all three
dose levels of 5 mcg, 15 mcg or 45 mcg induced robust immune
responses that are considered protective. 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.
These data confirmed that a single dose of 15 mcg was optimal to
induce robust immune responses in broader age populations with a
highly satisfactory safety profile.
"The success of Novavax's 2009 H1N1 VLP pandemic influenza
vaccine in the Mexico pivotal study clearly demonstrates the
desirable tolerability and immunogenicity profile of our vaccine
candidate in the largest clinical trial conducted by the Company to
date. We are highly encouraged by these results as the data meet
the immunogenicity criteria of both the United States and European
regulatory authorities. These data enable potential emergency use
of the vaccine in pandemic situations and could be supportive in
other countries in addition to Mexico. Based on these positive
data, we have filed for regulatory approval of our H1N1 VLP
pandemic influenza vaccine candidate in Mexico," said Dr. Rahul
Singhvi, President and Chief Executive Officer of Novavax. "The
substantial safety dataset and strong immunogenicity signal from
this large study provide us confidence as we plan Phase III studies
of our seasonal trivalent influenza VLP vaccine, pending results
from the ongoing Phase IIa trial in older volunteers and
discussions with the U.S. Food and Drug Administration
(FDA)."
Earlier this month, Novavax completed enrollment of a cohort of
over 3,500 volunteers in Stage B of this pivotal study. Over 2,500
of these volunteers received a single 15 mcg injection of Novavax's
unadjuvanted 2009 A/H1N1 VLP pandemic influenza vaccine while 1,000
of the volunteers received a placebo. The purpose of Stage B
portion of this clinical study was to evaluate safety of the VLP
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 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 Statements
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; the 2009 H1N1 vaccine must be manufactured
quickly, or it may not be available for sale in Mexico until after
the 2009/2010 influenza season has ended even if approved; our
ability to progress the seasonal product into Phase III clinical
studies; and the scope, initiation, rate and progress of such Phase
III or any other clinical study. 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, Senior Manager, Investor
Relations of
Novavax, Inc., +1-240-268-2031
Web Site: http://www.novavax.com/
Posted: March 2010
