Business Overview
Aeolus is developing its lead compound, AEOL-10150, as a treatment for the lung effects of Acute Radiation Syndrome (“Lung-ARS”) under a $118MM, 5 year contract from the Biomedical Advanced Research and Development Authority (“BARDA”), a division of the U.S. Department of Health and Human Services. The BARDA contract funds the development of AEOL-10150 through FDA approval under the Animal Rule. If the development program is successful, AEOL-10150 would be a candidate for procurement into the U.S. Strategic National Stockpile (the “Stockpile”) as a medical countermeasure for Lung-ARS.
The development work funded under the BARDA contract also supports part of the development costs for AEOL-10150 as a treatment for the side effects of radiation therapy for oncology. We plan to leverage the U.S. government investment to develop AEOL-10150 concurrently for use in an oncology setting. Based on the work currently underway under the contract, we believe we will be able to begin a Phase II study in radiation oncology in 2014.
AEOL-10150 is one of a new class of broad-spectrum catalytic antioxidant compounds based on technology developed at Duke University and National Jewish Health. These compounds, known as metalloporphyrins, scavenge reactive oxygen species (“ROS”) at the cellular level, mimicking the effect of the body’s own natural antioxidant enzyme superoxide dismutase (“SOD”). The neutralization of ROS reduces oxidative stress, inflammation, and subsequent tissue damage-signaling cascades resulting from radiation exposure.
While the benefits of antioxidants in reducing oxidative stress are well-known, research indicates our metalloporphyrins can also affect signaling via ROS at the cellular level. In addition, there is evidence that high-levels of ROS can affect gene expression and this may be modulated through the use of metalloporphyrins. We believe this could have a profound beneficial impact on people who have been exposed to high-dose radiation from a nuclear detonation or radiological event or in the course of receiving radiation therapy for cancer.
AEOL 10150 has been tested in two Phase I clinical trials with no serious adverse events reported. Data have already been published showing that AEOL 10150 does not interfere with the therapeutic benefit of radiation therapy in prostate and lung cancer preclinical studies.
We have two programs underway for the development of our second drug candidate, AEOL 11207, for the treatment of epilepsy and Parkinson’s disease. These programs are being funded, in part, by private foundations and government grants.