RESEARCH TRIANGLE PARK, NC (Sept. 7, 2004) – Aeolus Pharmaceuticals, Inc. said the Food & Drug Administration (FDA) has allowed Aeolus’ Investigational New Drug application (IND) to begin Phase 1 clinical trials of AEOL 10150 for the possible treatment of patients with amyotrophic lateral sclerosis (also known as “ALS” or “Lou Gehrig’s disease”).

ALS, the most common motor neuron disease, results from progressive degeneration of both upper and lower motor neurons and is usually fatal within five years of symptom onset. The Phase 1 clinical studies are designed to test the range of doses over which AEOL 10150 is safe in patients diagnosed with ALS.

The initial Phase 1 clinical trial will consist of a single dose of AEOL 10150 given to ALS patients to evaluate the safety, tolerability and pharmacokinetics of the drug. The single dose per patient will be increased as the trial progresses. If the Phase 1 clinical trial results are satisfactory in terms of safety, Aeolus’ clinical plan calls for initiating Phase 2 clinical trials of AEOL 10150 for the possible treatment of ALS.

Aeolus currently is negotiating with several clinical centers to initiate these Phase 1 clinical trials. Aeolus is also conducting additional preclinical tests to determine the optimum dose regimen to treat patients with AEOL 10150.

Aeolus said it is developing a new class of small molecule catalytic antioxidants that destroy oxygen-derived free radicals, believed to be an important contributor to the pathogenesis of many diseases. Aeolus’ catalytic antioxidants have been shown to reduce damage to tissue in animal studies of ALS, stroke, cancer and chronic obstructive pulmonary disease, the company said.