- Published: 15 May 2009
- Written by Editor
Novavax Completes Enrollment of Its Second Phase II Seasonal Influenza VLP Vaccine Clinical Trial
Completion of enrollment keeps Company on track to report primary study results in third quarter of this year
Novavax, Inc. (Nasdaq: NVAX) announced today that enrollment has been completed in the second Phase II clinical trial of its trivalent virus-like particle (VLP) seasonal influenza vaccine. This Phase IIa randomized, placebo-controlled study is evaluating a VLP vaccine against the H3N2, H1N1, and B influenza strains that circulated in the 2008-2009 influenza season. This clinical trial represents another step in the development of Novavax's VLP seasonal influenza vaccine, allowing further evaluation of safety and immunogenicity of a broad range of vaccine doses against a new set of influenza strains. As announced in December of 2008, the first Phase II study evaluated a trivalent VLP vaccine against the seasonal influenza strains that circulated in the 2005-2006 influenza season.
Specifically, this new study is evaluating the safety and immunogenicity of the 2008-2009 influenza vaccine in approximately 220 healthy adults between the ages of 18 and 49 years. Subjects have received a single injection of either a placebo or the VLP vaccine at doses of 15 mcg or 60 mcg per strain. The results of this study will be used to help select a dose for further evaluation in a clinical trial involving adults 65 years of age and older later this year and in a subsequent Phase III efficacy study.
"Enrollment of this second Phase II clinical trial represents another important developmental milestone for our VLP seasonal influenza vaccine program," said Dr. Rahul Singhvi, President and CEO of Novavax. "This study provides the opportunity to evaluate the safety and immunogenicity of our VLP vaccine against a new set of influenza strains, further strengthening our growing clinical database for VLP-based influenza vaccines. The completion of enrollment keeps us on track for having top line data for the 2008-2009 vaccine in the third quarter of this year and for selecting a dose for a Phase II trial in older adults later this year."
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 new, and efficient manufacturing approaches. Additional information about Novavax is available at www.novavax.com and in the Company's various filings with the Securities and Exchange Commission.
Forward Looking Statement
Statements herein relating to future development results and performance, conditions or strategies and other matters, including expectations regarding product and clinical developments, 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 relating to the early stage of Novavax's product candidates under development; current results may not be predictive of future pandemic results, results of our seasonal influenza vaccine or any other vaccine that we may develop; further testing is required before regulatory approval can be applied for and the FDA may not approve a vaccine even if further trial results are similar to those disclosed previously by the company; uncertainties relating to clinical trials; dependence on the efforts of third parties; competition for clinical resources and patient enrollment from drug candidates in development by other companies with greater resources and visibility; and risks that we may lack the financial resources and access to capital to fund our operations including further clinical trials. 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.