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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.
In clinical trials, Menveo has been shown to elicit a protective immune response against four of the most common serogroups - A, C, W-135 and Y - of Neisseria meningitides, also known as meningococcus. The symptoms, which can include sudden onset of fever, rash, headache and stiff neck, can progress rapidly.2 billion was invested in R&D activities throughout the Group. A number of treated animals continued to be monitored until the end of six months and analysis of those animals is currently underway.
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The FDA has requested additional information on the clinical and the CMC (Chemistry Manufacturing and Control) sections of the BLA. Even with early and appropriate treatment, between 10% and 14% of meningitis cases are fatal, typically within 24 to 48 hours[4],[5]. Journal of the American Medical Association.
“AEOL 10150 has consistently shown a protective effect against the harmful effects in radiation, including when the drug is administered up to 72 hours after exposure,” stated Zeljko Vujaskovic, M. 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. McManus, President and Chief Executive Officer of Aeolus Pharmaceuticals, Inc. This approach has the added benefit of not requiring biodosimetry (a means of laboratory analysis of the blood to determine the level of radiation exposure). Additionally, based on its mechanism, it is believed that the compound may potentially protect against exposure to chlorine gas. Studies funded by the National Institutes for Health are currently underway evaluating AEOL 10150 as a treatment for exposure to mustard gas and will shortly be initiated to evaluate the compound as a treatment for exposure to chlorine gas. Certain of these factors and others are more fully described in Aeolus' filings with the Securities and Exchange Commission, including, but not limited to, Aeolus' Annual Report on Form 10-K for the year ended September 30, 2008.
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