ROCKVILLE, Md., May 15 MD-Novavax-Clin-Trial
ROCKVILLE, Md., May 15 /PRNewswire-FirstCall/ -- Novavax, Inc.
(Nasdaq: NVAX) today announced that it has completed enrollment in the Phase
I/IIa study of its pandemic influenza vaccine including a total of
approximately 230 subjects. Favorable interim results from the first phase of
the study, which included dose-escalation in 70 healthy adult volunteers, were
reported in December 2007. The interim findings suggested that the vaccine is
well tolerated and immunogenic at the 15 microgram and 45 microgram dose
levels. Based upon its review of these results, the Data and Safety Monitoring
Board (DSMB) recommended that the study continue.
Enrollment has now been completed in the second phase of the trial, which
includes approximately 160 healthy adult volunteers. The safety and
immunogenicity of three vaccine doses (15 micrograms, 45 micrograms and 90
micrograms) as compared with placebo will be evaluated. Top-line results for
this trial are expected in the third quarter.
"This is an important study because the safety data collected in this
trial will also be used to support the safety database for our seasonal
influenza vaccine program which is expected to begin with a Phase IIa study in
the third quarter of this year. Completion of enrollment in the second portion
of this Phase I/IIa pandemic influenza vaccine trial keeps us on target to
announce top line results from this study in the third quarter," said Rahul
Singhvi, President and Chief Executive Officer.
ABOUT NOVAVAX
Novavax, Inc. is a clinical stage biotechnology company, creating novel
vaccines to address a broad range of infectious diseases worldwide using
advanced proprietary virus-like particle (VLP) technology. The Company
produces these VLP based, potent recombinant vaccines utilizing a new,
efficient manufacturing solution. Additional information about Novavax is
available at http://www.novavax.com and in the Company's various filings with
the Securities and Exchange Commission.
FORWARD LOOKING STATEMENTS
Statements herein relating to future financial or business performance,
conditions or strategies and other financial and business matters, including
expectations regarding revenues, operating expenses, cash burn, and clinical
developments and anticipated milestones 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 risks and uncertainties, including
the Company's ability to progress any product candidates in preclinical or
clinical trials; the scope, rate and progress of its preclinical studies and
clinical trials and other research and development activities; clinical trial
results; even if the data from preclinical studies or clinical trials is
positive, the product may not prove to be safe and efficacious; Novavax's
pilot plant facility is subject to extensive validation and FDA inspections,
which may result in delays and increases costs; the effect or outcome of the
Company's decision to sell Estrasorb(R); the human capital and other costs
Novavax will incur to exit the manufacturing facility; our ability to enter
into future collaborations with industry partners and the terms, timing and
success of any such collaboration; the cost of filing, prosecuting, defending
and enforcing any patent claims and other intellectual property rights; our
ability to obtain rights to technology; competition for clinical resources and
patient enrollment from drug candidates in development by other companies with
greater resources and visibility; our ability to obtain adequate financing in
the future through product licensing, co-promotional arrangements, public or
private equity or debt financing or otherwise; general business conditions;
competition; business abilities and judgment of personnel; and the
availability of qualified personnel. 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 http://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.
