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Cambridge, MA, June 30, 2009 - Novartis Vaccines and Diagnostics received feedback from the US Food and Drug Administration (FDA) in the form of an initial regulatory determination on the Biologics License Application (BLA) for the investigational vaccine Menveo. meningitidis). A number of treated animals continued to be monitored until the end of six months and analysis of those animals is currently underway.D.”
About AEOL 10150
AEOL 10150 is a small molecule that catalytically consumes reactive oxygen and nitrogen species (free radicals).
AEOL 10150 offers several unique advantages as a countermeasure for the treatment of ARS, mustard gas and chlorine gas for civilian and military populations.
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The BLA was submitted on August 28, 2008 for use of Menveo in subjects age 11 - 55. You should not place undue reliance on these statements. Additionally, mice receiving AEOL 10150 experienced a reversal in weight loss seen in the untreated mice. The remaining animals that received AEOL 10150 did not need to be sacrificed based on animal care rules, but a majority were sacrificed in order to increase the numbers that could be compared to the untreated animals sacrificed at 45 days, since there would be no untreated animals for comparison at the end of six months. Our objective now is to determine how long after exposure we can administer the drug and achieve significant benefits and to more clearly identify the appropriate dose and dosing regimen.05) survival advantage, statistically significant differences in body weights and wet lung weights were seen over the first six weeks of the study.
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