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The BLA was submitted on August 28, 2008 for use of Menveo in subjects age 11 - 55. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 98,000 full-time-equivalent associates and operate in more than 140 countries around the world. (OTC Bulletin Board:AOLS) announced today that data from a study in which AEOL 10150 was administered to 40 mice who had been exposed to radiation show a statistically significant increase in survival rates among mice who were treated with AEOL 10150 compared to controls. “We believe AEOL 10150 could be a compelling countermeasure for Acute Radiation Syndrome (“ARS”) and are committed to working with our partners at Duke University, the University of Maryland and the National Institutes of Health (NIH) National Institutes of Allergies and Infectious Diseases (NIAID) to accelerate the development and approval of this product with the goal of providing protection against nuclear and radiological threats to the citizens of our country.
AEOL 10150 offers several unique advantages as a countermeasure for the treatment of ARS, mustard gas and chlorine gas for civilian and military populations. 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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Studies have reported that Menveo generates a robust immune response against the four vaccine-preventable serogroups, A, C, W-135 and Y in people across age groups from infancy to adulthood. Ph. 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. Doses in the range of 5 to 10 mg/kg/d showed a more potent effect including more significant mitigation as assessed by histopathology and immunohistochemistry. Research has shown that ROS and RNS have important cell signaling roles, and through its interaction with RNS and ROS, AEOL 10150 appears to have multiple mechanisms of action including anti-oxidant, anti-inflammatory and anti-angiogenic activities. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Aeolus' actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. Important factors that could cause results to differ include risks associated with uncertainties of progress and timing of clinical trials, scientific research and product development activities, difficulties or delays in development, testing, obtaining regulatory approval, the need to obtain funding for pre-clinical and clinical trials and operations, the scope and validity of intellectual property protection for Aeolus' product candidates, proprietary technologies and their uses, and competition from other biopharmaceutical companies.
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