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May 12, 2014
09:28 EDTNVAXNovavax says data support accelerating plans for 'seasonal' elderly RSV vaccine
Novavax announced follow-up data from its dose-ranging Phase 1 clinical trial of its respiratory syncytial virus F-protein vaccine in 220 elderly adults that was initiated in October 2012. In the placebo-controlled trial, subjects received a single injection of either 60g or 90g of the RSV F-protein vaccine candidate, with or without aluminum phosphate as an adjuvant. In the one-year follow up data released by Novavax, the company reported that the group receiving the 90g dose without adjuvant, anti-F levels and PCA were significantly elevated over baseline at day 118, with a geometric mean of 130g/ml, and at day 180, with a geometric mean of 114g/ml. The company said, "We were pleased to see that a 90g dose of our RSV F vaccine candidate was immunogenic and sustained levels that appear to be protective over an entire RSV season. These results encourage us to accelerate our development plans to include an annual seasonal RSV vaccine for the elderly where there is a burden of disease and incidence rate similar to that of an influenza virus, and clearly support initiation of a Phase 2 clinical trial as early as later this year or early-2015."
News For NVAX From The Last 14 Days
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September 19, 2014
07:41 EDTNVAXNovavax coverage assumed with an Outperform at Wedbush
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September 18, 2014
11:16 EDTNVAXNovavax to host analyst and investor day
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September 16, 2014
16:09 EDTNVAXNovavax initiates Phase 2 trial of RSV F vaccine candidate
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September 7, 2014
12:31 EDTNVAXNovavax presents data on RSV F nanoparticle vaccine induced monoclonal antibody
Novavax presented preclinical data demonstrating that antibodies generated to its RSV F-protein nanoparticle vaccine candidate bind to the site II epitope of the RSV F-protein with a higher affinity than palivizumab, Syangis, at the 54th Interscience Conference on Antimicrobial Agents and Chemotherapy, ICAAC, in Washington, DC. In poster session 024: I-314b titled "Development and Characterization of Recombinant RSV Nanoparticle Vaccine Induced Monoclonal Antibody.", Novavax used its RSV F vaccine to generate a murine monoclonal antibody, NVX4C6, that binds to the antigenic site II on the RSV F-protein. Using Surface Plasmon Resonance, Novavax was able to compare the binding affinity of NVX4C6 and palivizumab to the antigenic site II. This experiment demonstrated that Novavax' RSV F vaccine can induce antibodies to the antigenic site II that have a higher binding affinity to the site than palivizumab. In addition, NVX4C6 was shown to have a slightly different specificity to the site II epitope and to recognize mutated site II peptide not recognized by palivizumab, suggesting that NVX4C6 may neutralize palivizumab escape mutants.

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