Sep 14 2009
Aeolus Pharmaceuticals, Inc. (OTC Bulletin Board: AOLS) announced today the initiation of a second study, in mice, to determine the optimal length of treatment with AEOL 10150 when used as a countermeasure to Acute Radiation Syndrome (ARS) in the lungs. This study, led by Zeljko Vujaskovic, M.D. Ph.D. of Duke University, is designed to build on the recently completed study that demonstrated the efficacy of AEOL 10150 as a treatment for damage to the lungs due to exposure to radiation, and determine the most effective duration of delivery for treatment after exposure.
AEOL 10150 has been shown to be safe and well tolerated in two phase 1 safety studies, and in animal studies it has been proven to be efficacious in protecting the lungs from radiation damage and increasing survival at doses in the range of 5 to 30 mg/kg given daily up to 24 hrs after irradiation and administered for as long as 10 weeks. The compound mitigated functional lung injury in rats and led to a statistically significant survival advantage in mice. In rodents and humans, radiation of the lungs can cause reduced breathing capacity, pneumonitis, fibrosis, weight loss and death and is characterized by oxidative stress, inflammation and elevated macrophage counts. AEOL 10150 has proven to be an effective countermeasure to radiation exposure of the lungs in mice and rats.
“This study will provide important insight into the most appropriate length of treatment with AEOL 10150 to protect the lungs following exposure to radiation,” stated John L. McManus, President and Chief Executive Officer of Aeolus Pharmaceuticals, Inc. “The results of this study will be critical in helping us design the pivotal study in mice, which we expect will be one of the two species necessary for approval of AEOL 10150 as a countermeasure to nuclear threats under the US FDA’s Animal Rule.”
www.aeoluspharma.com