Aeolus files IND with FDA for radiation countermeasure

Aeolus Pharmaceuticals, Inc., announced on Wednesday that it filed an investigational new drug application (IND) with the U.S. Food and Drug Administration to enable a Phase I study of its radiation countermeasure.

AEOL 10150, a broad-spectrum catalytic antioxidant, is designed to reduce oxidative stress, inflammation and tissue damage resulting from radiation exposure. Aeolus' Phase I study is meant as the first step in meeting the requirements for approval of AEOL 10150 as a medical countermeasure for lung damage due to radiation exposure (Lung-ARS) under the FDA's animal rule.

"The filing of our IND for Lung-ARS is the culmination of a tremendous effort by our development team, and was made possible by (the Biomedical Advanced Research and Development Authority (BARDA))'s investment in our technology and the valuable input and guidance we have received our BARDA Project Coordination Team and from the Medical Imaging Products Division and Office of Counter-Terrorism and Emergency Coordination at the FDA," John McManus, the president and CEO of Aeolus, said.

Aeolus is developing AEOL 10150 under a five-year contract with BARDA valued at up to $118 million.

"I am grateful for the hard work and commitment of our employees and consultants and for the collaborative partnership we have with BARDA," McManus said. "As a result of our team's efforts and BARDA's investment and valuable input into our program, we are prepared to initiate a human safety study for Lung ARS Medical Countermeasure program once we have FDA clearance, and plan to quickly follow this study, with our first human studies in cancer."

If the FDA accepts the IND and clinical protocol and BARDA exercises the necessary program options, Aeolus will initiate a Phase I study in healthy normal volunteers during 2014's fourth quarter.

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Aeolus Pharmaceuticals

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