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LAGUNA NIGUEL--- Aeolus Pharmaceuticals Initiates Pivotal Animal Study of AEOL 10150 as a Countermeasure to Radiation Exposure |
| 11/21/2008 @ 7:58 AM
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Aeolus Pharmaceuticals, Inc. (OTCBB: AOLS) announced today that it has initiated the first of two expected pivotal studies of AEOL 10150 as a countermeasure to nuclear and radiological exposure. The study, led by Zeljko Vujaskovic, M.D. Ph.D. of Duke University, is designed to test the efficacy of AEOL 10150 as a treatment for damage to the lungs due to exposure to radiation and to determine the most effective dose, duration of delivery and the window of opportunity for treatment after exposure. Results from this study will lead to the final design of a pivotal study which is expected to begin early in 2009.
The new study builds on results from previous studies [Rabbani Z. et al 2007] where it was shown that doses in the range of 5 to 30 mg/kg AEOL10150 given daily starting up to 24 hrs after irradiation and administered for as long as 10 weeks mitigate functional lung injury in Fischer 344 rats. Doses in the range of 5 to 10 mg/kg/d showed the more potent effect including more significant mitigation as assessed by histopathology and immunohistochemistry.
“Initiating this study is a critical milestone for Aeolus, as it represents the first of two pivotal animal studies that we expect will be necessary for approval of AEOL 10150 as a countermeasure for Acute Radiation Syndrome (“ARS”) under the FDA’s animal rule,” stated John L. McManus, President and Chief Executive Officer of Aeolus Pharmaceuticals, Inc. “We are grateful to Dr. Vujaskovic for his participation in this program, and the contribution that this study may make to providing protection against nuclear and radiological threats against the citizens of our country.”
About AEOL 10150
AEOL 10150 is a small molecule that catalytically consumes reactive oxygen and nitrogen species (free radicals). The compound is a manganoporphyrin that contains a positively-charged manganese metal ion that is able to accept and give electrons to and from reactive oxygen species (“ROS”) and reactive nitrogen species (“RNS”). 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. In animal studies AEOL 10150 has demonstrated reductions in the markers for tissue hypoxia, angiogenesis, inflammation and oxidative stress. Specifically, AEOL 10150 is able to down-regulate oxidative stress and severe inflammation, which is responsible for much of the tissue destruction that occurs as a result of radiation exposure.
AEOL 10150 offers several unique advantages as a countermeasure for the treatment of ARS, mustard gas and chlorine gas for civilian and military populations. These include:
- - Flexible Treatment Paradigm – AEOL 10150 is intended for the treatment of patients post-exposure, even in those who are already exhibiting symptoms, eliminating the need for immediate administration in a predefined treatment window. 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).
- - Advanced Development Stage – AEOL 10150 has demonstrated safety in three human clinical trials, and has an extensive pre-clinical safety and toxicology package completed. The product also has an established stability profile that permits long-term storage.
- - Large scale manufacturing – Aeolus has contract capacity with a large manufacturing site to mass produce large quantities of AEOL 10150 under GMP conditions.
- - Multiple Applications – AEOL 10150 has demonstrated protective effects against radiation and mustard gas exposure, and within these indications has shown the ability to treat multiple organ systems.
- - Commercial Application – Additionally, AEOL 10150 is being developed for use as an adjunct to cancer radiation therapy, and animal data suggest that the compound protects healthy normal cells from the effects of radiation without compromising the efficacy of the radiation in killing tumor cells.
Potential for AEOL 10150 as a Countermeasure Against Multiple Terrorist Threats
AEOL 10150 has shown significant protective effects against radiation and mustard gas in animal models. Additionally, based on its mechanism, it is believed that the compound may potentially protect against exposure to chlorine gas. Studies will shortly be initiated to further explore AEOL 10150’s ability to protect the skin and lungs from damage due to exposure to mustard gas, and to protect the lungs from exposure to chlorine gas. A compound with the potential to protect against multiple threats would be of significant benefit in both the military and civilian efforts to protect citizens against potential threats. The FDA has a special “Animal Rule” under which compounds may be approved for use against chemical and nuclear threats on the strength of animal efficacy studies, which allows the potential for an accelerated approval path versus conventional pharmaceutical applications.
About Aeolus Pharmaceuticals
Aeolus is developing a variety of therapeutic agents based on its proprietary small molecule catalytic antioxidants, with AEOL 10150 being the first to enter human clinical evaluation. AEOL 10150 is a patented, small molecule catalytic antioxidant that mimics and thereby amplifies the body’s natural enzymatic systems for eliminating reactive oxygen species, or free radicals. 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. Additionally, the Company has initiated animal studies necessary to seek approval of the compound as a treatment to protect the lungs from exposure to radiation. |
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