BioCentury
ARTICLE | Clinical News

Aeolus preclinical data

July 22, 2013 7:00 AM UTC

In rats, subcutaneous AEOL 10150 following sulfur mustard gas exposure significantly improved survival by up to 82% over 48 hours after exposure vs. saline-treated controls. AEOL 10150 also improved pulse oximetry (p<0.0001), reduced clinical scores of respiratory quality and activity by >60% at 48 hours (p<0.005) and reduced airway cast formation by 50% at 24 hours (p<0.017) vs. controls. Separately, subcutaneous and topical treatment with AEOL 10150 following exposure to nitrogen mustard gas in mice led to a 100% survival rate at 120 hours after exposure vs. 38% for untreated controls. AEOL 10150 also reversed epidermal thickness and microvesication at 120 hours post-exposure vs. controls (p<0.05 for both). Data were presented at the CounterACT Countermeasures Against Chemical Threats meeting in Washington, D.C.

Aeolus plans to meet with FDA to discuss the design of a pivotal study in rats for mustard gas exposure and an appropriate second species to satisfy the requirements of FDA's Animal Rule. The Animal Rule allows marketing approval to be granted based on efficacy in relevant animal models and an acceptable safety risk profile in humans. In 2011, NIH's Countermeasures Against Chemical Threats Research Network (CounterACT) awarded researchers at National Jewish Health hospital a $12.7 million, 5-year contract to partially fund continued preclinical development of AEOL 10150 to treat mustard gas and chlorine gas exposure. ...