Aeolus Pharmaceuticals (OTCBB:AOLS) reported on Friday it has filed an orphan drug application with the U.S. FDA to get orphan designation status for its clinical stage drug AEOL 10150, to treat delayed effects of Acute Radiation Exposure (ARE) in the lung.
The biotech company, which is leveraging about $140 million of government funding to develop a new class of catalytic-antioxidant drugs against ARE, said filing the application is an important step to its drug development strategy.
The U.S. Orphan Drug Act of 1983 is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders.
Orphan drug designation means that the company qualifies for certain benefits, such as reduced taxes, from the federal government.
The drug, AEOL 10150, could also have a beneficial impact on people who have been exposed, or are about to be exposed, to high-doses of radiation in the treatment of oncology.
AEOL 10150 is a broad-spectrum catalytic-antioxidant specifically designed to neutralize reactive oxygen and nitrogen species. The neutralization reduces oxidative stress, inflammation and tissue damage that results from radiation exposure.
Thus far, the drug has already performed well in pre-clinical and non-clinical studies. It has been well tolerated in two human clinical trials, and also demonstrated major survival efficacy in acute radiation-induced lung injury.
The compound is being developed for oncology indications, where it is used in combination with radiation therapy. It is also being developed, with funding by the U.S. Government, as a medical counter-measure against chemical and radiological weapons.
Aeolus Pharmaceuticals, formerly Incara Pharmaceuticals Corp, is developing a platform of a new class of catalytic-antioxidant compounds that protects healthy tissue from the damaging effects of radiation.