Novavax, Inc. 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.
Source: http://www.novavax.com