ROCKVILLE, Md., March 18, 2013 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) reported that David C. Flyer, Ph.D., Director of Preclinical Development at Novavax, presented recent preclinical findings from the company's respiratory syncytial virus (RSV) vaccine development program at the XV International Symposium on Respiratory Viral Infections in Rotterdam, the Netherlands. He reported that in preclinical studies, Novavax' RSV vaccine candidate induced anti-RSV antibodies capable of neutralizing RSV in vitro and significantly reduced infectious RSV in a cotton rat challenge model. Further, in both clinical and preclinical studies, he reported that palivizumab-competing antibodies were generated at titers significantly above that found to be protective in both humans and cottons rats.
Dr. Flyer stated during his presentation: "Both the human and cotton rat data suggest that our RSV vaccine candidate induced robust antibody responses with activity similar to palivizumab, which is a licensed anti-RSV monoclonal antibody indicated for the prevention of RSV disease in at-risk children and infants. These data provide further scientific evidence that our vaccine candidate may have the potential to safely protect infants in the first few months of life, where morbidity and mortality from RSV is greatest, as well as other affected populations including pediatric and elderly patients."
In October 2012, the company initiated two separate dose-ranging clinical trials, one in women of child bearing age and the other in elderly adults. The first trial is a randomized, blinded, placebo-controlled Phase II clinical trial evaluating the safety and immunogenicity of two dose levels of the RSV vaccine candidate with and without an aluminum phosphate adjuvant, with 330 women of childbearing age enrolled. Top-line data from this trial are expected to be announced in April 2013. The second trial is a randomized, blinded, placebo-controlled Phase I clinical trial evaluating the safety and immunogenicity of two doses of the RSV vaccine candidate, also with and without aluminum phosphate as an adjuvant, with 220 elderly adults enrolled. Top-line data from this trial are expected to be reported later in the second quarter of 2013.
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 candidates 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, 2012, 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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