ROCKVILLE, Md., Oct. 15, 2012 (GLOBE NEWSWIRE) -- Novavax, Inc.(Nasdaq:NVAX) today announced that enrollment has begun in a Phase 1 dose-ranging clinical trial of its respiratory syncytial virus (RSV) vaccine candidate in healthy adults 60 years of age and older.
This randomized, blinded, placebo-controlled Phase 1 study will evaluate the immunogenicity and safety of two doses of Novavax' RSV-F nanoparticle protein micelle vaccine candidate with and without aluminum phosphate as an adjuvant. The study is similar to the recently launched Phase 2 RSV study in women of childbearing age but will enroll 220 adults 60 years of age and older who will receive a single intramuscular injection of Novavax' RSV-F nanoparticle protein micelle vaccine or placebo plus a single dose of licensed influenza vaccine or placebo at days 0 and 28. Safety and immunogenicity will be evaluated for up to one year.
"Respiratory syncytial virus is a frequent cause of winter respiratory illnesses in the elderly and in some seasons can equal or exceed influenza's rates of disease requiring medical attention. This study extends our clinical program designed to meet this population's need for an RSV vaccine. The study will evaluate the safety and immunogenicity of our RSV vaccine candidate in elderly adults and will help us determine the optimal dosing regimen for future studies," said Gregory Glenn M.D., Senior Vice President and Chief Medical Officer of Novavax. "We expect to report top-line results from this study in the second quarter of 2013."
RSV is a major respiratory pathogen in infants, children, and adults. RSV infections in adults represent re-infections and are generally mild to moderate in severity, except in persons with high-risk conditions including the elderly and adults with underlying chronic cardiac or pulmonary disease. It is estimated that between 11-17,000 adults die of RSV infection annually in the U.S., with and up to 180,000 admitted to hospital with respiratory symptoms. Currently, there is no approved RSV prophylactic vaccine available.
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines to address a broad range of infectious diseases worldwide. Using innovative recombinant protein nanoparticle vaccine technology, as well as new and efficient manufacturing approaches, the company produces 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, LG Life Sciences of Korea and PATH. Together, these organizations support Novavax' worldwide commercialization strategy and have 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 recombinant nanoparticle 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, 2011, 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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