Novavax to Report Top-Line Results From Phase I Respiratory Syncytial Virus Vaccine Clinical Trial on October 3rd at 5th Vaccine and ISV Annual Global Conference
ROCKVILLE, Md., Sep 26, 2011 (GlobeNewswire via COMTEX) --
Novavax, Inc. (Nasdaq:NVAX) today announced that it will report top-line results from a Phase I clinical trial of its respiratory syncytial virus (RSV) vaccine candidate in a presentation at the 5th Vaccine and ISV Annual Global Conference in Seattle on October 3, 2011. The presentation is titled, "Recombinant micellar RSV F vaccine for respiratory disease: Antigen characterization, preclinical efficacy and clinical evaluation" and will be made by Gregory M. Glenn, M.D., Senior Vice President and Chief Medical Officer of Novavax.
The blinded, placebo-controlled, dose-escalating Phase I trial was launched in January 2011 to assess the safety, immunogenicity and tolerability of Novavax's vaccine candidate against RSV. The study enrolled 150 healthy adults 18 to 49 years old who were allocated to six cohorts and randomized to receive vaccine treatment or saline placebo in a 4:1 ratio.
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.
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines to address a broad range of infectious diseases worldwide. Using innovative virus-like particle (VLP) and recombinant nanoparticle technology, as well as new and efficient manufacturing approaches, the company produces potent vaccine candidates to combat diseases, with the goal of allowing countries to better prepare for and more effectively respond to rapidly spreading infections. Novavax is committed to using its technology platforms to create geographic-specific vaccine solutions and is therefore involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India and LG Life Sciences of Korea. Together, these companies have worldwide commercialization capacity and the global reach to create real and lasting change in the biopharmaceutical field. Additional information about Novavax is available on the company's website: www.novavax.com.
Forward Looking Statements
Statements herein relating to the future of Novavax and its ongoing development of its VLP vaccine products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2010, and filed with the Securities and Exchange Commission. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.
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SOURCE: Novavax, Inc.
CONTACT: Frederick W. Driscoll VP, Chief Financial Officer and Treasurer Novavax, Inc. 240-268-2000