Clinical and pre-clinical studies
The goal of our research is FDA approval for AEOL 10150 as a safe and effective medical countermeasure to mitigate radiation-induced pulmonary injury and exposure to chemical vesicants.
AEOL 10150 has already performed well in animal safety studies, been well-tolerated in two human clinical trials and demonstrated efficacy in two species in Lung-ARS studies. AEOL 10150 treated groups showing significantly reduced weight loss, inflammation, oxidative stress, lung damage, and most important, mortality. Therapeutic efficacy was demonstrated when delivered after 24 hours after exposure to radiation.
AEOL 10150 has also demonstrated efficacy in validated animal models for chlorine gas exposure, sulfur mustard gas exposure and exposure to a surrogate for nerve gas.
Pulmonary injury (Lung) sub-syndrome in ARS
AEOL 10150 is currently at Technical Readiness Level (“TRL”) 7 as a medical countermeasure for Lung-ARS caused by exposure to high levels of radiation due to a radiological or nuclear event.
Lung-ARS studies are 6 month studies due to the longer time period during which the syndrome develops and causes death. These studies will form the basis for a pre-EUA filing by BARDA that would be the first step in moving to a procurement of AEOL-10150 for the U.S. Strategic National Stockpile.
Under the BARDA contract, we expect to run an additional Phase I human safety study with AEOL-10150 in 50-60 healthy normal volunteers in the second half of 2014. AEOL-10150 has already been in two Phase I human safety studies and where it was well tolerated and demonstrated no adverse effects. The additional Phase I study is expected to be completed in 1H 2015.
Chemical Vesicants (Sulfur Mustard Gas, Chlorine Gas)
Research with AEOL 10150 as a medical countermeasure for exposure to chemical vesicants such as sulfur mustard gas and chlorine gas is funded by grant money from the NIH CounterACT program. Multiple studies have demonstrated that AEOL 10150 treatment significantly improved survival in rats exposed to lethal doses of sulfur mustard gas. In addition, treatment with AEOL 10150 returned lung function to normal levels.
We intend to file an IND for AEOL 10150 as treatment for exposure to sulfur mustard gas. In order to gain approval, we are seeking FDA guidance on a large animal for this indication that would satisfy the requirements of the Animal Rule.
Nerve Agents (Sarin Gas, Soman Gas)
Research with AEOL 10150 as a medical countermeasure for exposure nerve agents is funded by grant money from the NIH CounterACT program. Animal studies have demonstrated that AEOL 10150 provides neuroprotection, decreases oxidative stress, and significantly improves survival in rats exposed to pilocarpine -- a surrogate for the nerve agents soman and sarin gas. Nerve agents, such as sarin gas, have been used in Syria, Iraq and Japan and pose a threat to civilian and military personnel. Sarin gas exposure can cause pain, weakness, vomiting, diarrhea and changes in heart rate within minutes to 18 hours after exposure. High levels of exposure can cause convulsions, paralysis, breathing problems and death.
The pilocarpine model is also used as a pre-clinical model for epilepsy research, opening up a new potential indication for AEOL 10150.We continuing development of AEOL 10150 in this indication under a $4.3MM grant from NIH. Additional results from animal studies are expected in early 2015.