BioCentury
ARTICLE | Clinical News

Aeolus preclinical data

October 6, 2014 7:00 AM UTC

In non-human primates, AEOL 10150 given for 60 days increased survival to 50% from 25% at 180 days after radiation exposure to the lungs. Aeolus said the data will be included in a pre-emergency use authorization submission to FDA. AEOL 10150 is being developed under FDA's Animal Rule, which allows marketing approval to be granted based on efficacy in relevant animal models and an acceptable safety risk profile in humans. AEOL 10150 has Orphan Drug designation in the U.S. to treat or mitigate ARS in patients exposed to radiation following a nuclear accident or detonation. Aeolus is developing the product to treat pulmonary and delayed effects of acute radiation exposure under a 5-year contract with HHS's Biomedical Advanced Research and Development Authority (BARDA) (see BioCentury, Sept. 23, 2013). ...