Novavax, Inc. and University of Massachusetts Medical School Publish Preclinical Safety and Efficacy Study of a Respiratory Syncytial Virus (RSV) Virus-like Particle (VLP) Vaccine Candidate
The publication describes the production and testing of a novel RSV VLP vaccine candidate. Immunization with this genetically engineered RSV VLP vaccine stimulated immune response against key vaccine targets, the RSV G attachment and RSV F fusion proteins. The antibody responses achieved with this vaccine candidate were equal to or better than levels resulting from infection with live RSV. This RSV G+F VLP vaccine stimulated both anti-G and anti-F protein serum antibodies typical of a more Th1-biased response characteristic of natural infection with RSV. When challenged with live RSV, animals immunized with RSV VLPs were completely protected from replication of the virus in the lungs and showed no signs of enhanced respiratory disease.
"This study indicates that immunization with a VLP vaccine results in functional and protective immune responses against RSV. Induction of such functional, protective immunity has been a key challenge in RSV vaccine development. RSV is the leading global cause of infant and childhood respiratory disease, and these encouraging preclinical safety and efficacy data suggest that an RSV VLP vaccine is a promising approach and should be developed further," said Greg Glenn, M.D., Novavax's Chief Scientific Officer.
About Respiratory Syncytial Virus
RSV is the most important viral cause of lower respiratory tract infection in infants and children worldwide. The global disease burden is estimated at 64 million cases and 160,000 deaths every year. RSV is the most common cause of bronchiolitis (inflammation of the small airways in the lung) and pneumonia in children under 1 year of age in the United States. Each year, 75,000 to 125,000 children in this age group are hospitalized due to RSV infection. Almost all children will have had an RSV infection by their second birthday. When infants and children are exposed to RSV for the first time, 25% to 40% of them have signs or symptoms of bronchiolitis or pneumonia, and 0.5% to 2% will require hospitalization. Most children hospitalized for RSV infection are under 6 months of age. Additionally, wheezing illnesses caused by RSV, particularly those severe enough to lead to hospitalization, are associated with an increased risk of asthma at school age.
It is also estimated that more than 8.5 million adults, including the elderly over age 65 years, are infected and 900,000 patients are hospitalized annually due to RSV infection in the United States and major European countries. In the United States alone there are 177,500 hospitalizations among high risk adults resulting in annual medical costs exceeding $1 billion. There is currently no approved vaccine for the prevention of RSV; the market potential for such a vaccine would be well in excess of $1 billion annually.
About the University of Massachusetts Medical School
The University of Massachusetts Medical School is one of the fastest growing academic health centers in the country and has built a reputation as a world-class research institution, consistently producing noteworthy advances in clinical and basic research. The Medical School attracts more than $255 million in extramural research funding annually. Research dollars enable UMMS scientists to explore human disease from the molecular level to large-scale clinical trials. Basic and clinical research has led to new approaches for diagnosis, treatment and prevention of disease. Visit www.umassmed.edu for additional information.
About Novavax
Novavax, Inc. is a clinical-stage biopharmaceutical 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.
Cautionary Note Regarding Forward-Looking Statements
Statements herein relating to the results of preclinical tests are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. We caution readers not to place significant reliance on forward-looking statements contained in this release. Factors that may cause actual results to differ materially from the results discussed in forward-looking statements are contained in Novavax's filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov, including the factors discussed under the caption "Risk Factors" in our Annual Report on Form 10-K for the fiscal year ended December 31, 2009, as updated by our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2010, June 30, 2010, and September 30, 2010. These forward-looking statements speak only as of the date of this press release and Novavax assumes no duty to update such statements.
SOURCE Novavax, Inc.