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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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October 17, 2014
08:28 EDTNVAXNovavax management to meet with JPMorgan
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October 16, 2014
11:15 EDTNVAXHigh option volume stocks
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October 15, 2014
08:40 EDTNVAXNovavax RSV F Vaccine study evoked polyclonal antibody response
Novavax announced that its RSV F-protein nanoparticle vaccine candidate, or RSV F Vaccine, evoked a polyclonal antibody response to antigenic site II, the same site targeted by the monoclonal antibody palivizumab, resulting in protection from an RSV challenge in an animal model. Researchers at Novavax reported these findings in an online paper published by Vaccine titled: "An insect cell derived respiratory syncytial virus F nanoparticle vaccine induces antigenic site II antibodies and protects against RSV challenge in cotton rats by active and passive immunization." Greg Glenn, SVP, Research and Development at Novavax stated, "This study further characterizes the immune response to our RSV F Vaccine, including the production of both polyclonal palivizumab competing antibodies that target antigenic site II, as well as other neutralizing antigenic sites on the F-protein. In addition, our ability to assess the safety of our RSV F Vaccine relative to Lot 100 formalin inactivated vaccine, which is known to cause disease enhancement, and to demonstrate that our vaccine's efficacy is equivalent or better than palivizumab, gives us greater confidence that our RSV vaccine candidate will be both safe and effective."
October 14, 2014
08:40 EDTNVAXNovavax initiates Phase 2 clinical trial of RSV F vaccine
Novavax announced that enrollment has begun in a Phase 2 clinical trial of its respiratory syncytial virus, or RSV, F-protein nanoparticle vaccine candidate, in healthy elderly subjects. The trial is a randomized, observer-blinded, placebo-controlled Phase 2 study scheduled to enroll 1,600 elderly subjects at ten sites in the United States. The trial will evaluate the incidence of all respiratory illnesses due to RSV, including medically-attended respiratory illnesses due to RSV, and hospitalizations for respiratory illness due to RSV in community-living elderly adults who have been treated with placebo. The study will also evaluate the safety and immunogenicity of a 135g dose of the RSV F Vaccine compared with placebo. The trial will also estimate the efficacy of the RSV F Vaccine in reducing the incidence of respiratory illnesses due to RSV.

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