Novavax Publishes Preclinical Efficacy Study of its RSV Protein Nanoparticle Vaccine Candidate
ROCKVILLE, Md., Dec. 3, 2012 -- Novavax, Inc. (Nasdaq:NVAX) today announced that the journal PLOS ONE (http://dx.plos.org/10.1371/journal.pone.0050852) published data from a preclinical study of its recombinant nanoparticle vaccine candidate against respiratory syncytial virus (RSV), demonstrating efficacy and safety in a well-established animal model. These data indicated that the use of an RSV fusion (F) protein nanoparticle vaccine that induced high levels of specific neutralizing antibodies protected animals from both RSV replication and disease.
"The data from this preclinical model demonstrated the potential of our RSV F nanoparticle vaccine candidate to elicit the level and type of immunity required to protect humans as measured by virus neutralization activity," said Gale Smith, PhD, Novavax' Vice President of Vaccine Development. "Furthermore, our RSV vaccine candidate showed no sign of immunological disease enhancement which has plagued RSV vaccine development to date."
Severe RSV infection is the leading cause of infant hospitalization in the U.S., and globally there are 64 million cases and 160,000 deaths annually. Approximately one-half of all infants are infected with RSV during the first year of life, and nearly all children are infected at least once by the time they reach their second birthday. RSV also accounts for significant morbidity and mortality among the elderly, and adults with cardio-pulmonary compromise. There is currently no approved RSV prophylactic vaccine to address this critical unmet health care need.
"This publication describes important supportive evidence of the potential safety and efficacy of our RSV nanoparticle vaccine, and the rationale for the choice of the specific vaccine antigen," said Dr. Gregory Glenn, MD and Chief Scientific Officer for Novavax. "We have completed a Phase I trial and recently initiated two separate dose-ranging clinical trials of the RSV F nanoparticle vaccine candidate in the elderly (Phase I) and in women of child-bearing age (Phase II). These preclinical observations are consistent with the promising safety and immunogenicity seen in our clinical trials reported to date and suggest that this vaccine should continue to be developed."
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company creating vaccines to address a broad range of infectious diseases worldwide. Using innovative recombinant nanoparticle 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.
Statements herein relating to the future of Novavax and its ongoing development of its 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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Source: Novavax, Inc.