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Enrollment has now been completed in the second phase of the trial, whichincludes approximately 160 healthy adult volunteers. The safety andimmunogenicity of three vaccine doses (15 micrograms, 45 micrograms and 90micrograms) as compared with placebo will be evaluated. Top-line results forthis trial are expected in the third quarter.
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"This is an important study because the safety data collected in thistrial will also be used to support the safety database for our seasonalinfluenza vaccine program which is expected to begin with a Phase IIa study inthe third quarter of this year. Completion of enrollment in the second portionof this Phase I/IIa pandemic influenza vaccine trial keeps us on target toannounce top line results from this study in the third quarter," said RahulSinghvi, President and Chief Executive Officer.
ABOUT NOVAVAX
Novavax, Inc. is a clinical stage biotechnology company, creating novelvaccines to address a broad range of infectious diseases worldwide usingadvanced proprietary virus-like particle (VLP) technology. The Companyproduces these VLP based, potent recombinant vaccines utilizing a new,efficient manufacturing solution. Additional information about Novavax isavailable at http://www.novavax.com and in the Company's various filings withthe 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, includingexpectations regarding revenues, operating expenses, cash burn, and clinicaldevelopments and anticipated milestones are forward-looking statements withinthe meaning of the Private Securities Litigation Reform Act. Novavax cautionsthat these forward-looking statements are subject to numerous assumptions,risks and uncertainties, which change over time. Factors that may cause actualresults to differ materially from the results discussed in the forward-lookingstatements or historical experience include risks and uncertainties, includingthe Company's ability to progress any product candidates in preclinical orclinical trials; the scope, rate and progress of its preclinical studies andclinical trials and other research and development activities; clinical trialresults; even if the data from preclinical studies or clinical trials ispositive, the product may not prove to be safe and efficacious; Novavax'spilot plant facility is subject to extensive validation and FDA inspections,which may result in delays and increases costs; the effect or outcome of theCompany's decision to sell Estrasorb(R); the human capital and other costsNovavax will incur to exit the manufacturing facility; our ability to enterinto future collaborations with industry partners and the terms, timing andsuccess of any such collaboration; the cost of filing, prosecuting, defendingand enforcing any patent claims and other intellectual property rights; ourability to obtain rights to technology; competition for clinical resources andpatient enrollment from drug candidates in development by other companies withgreater resources and visibility; our ability to obtain adequate financing inthe future through product licensing, co-promotional arrangements, public orprivate equity or debt financing or otherwi
