AEOLUS REPORTS POSITIVE SAFETY RESULTS FROM ALS TRIAL

Aeolus Pharmaceuticals has announced the results of its multicenter, double-blind, randomized, placebo-controlled, Phase I clinical trial. This escalating single-dose study was conducted to evaluate the safety, tolerability and pharmacokinetics of AEOL 10150, which was administered by subcutaneous injection in patients with amyotrophic lateral sclerosis (ALS, or Lou Gehrig's disease).

In the study, four or five patients diagnosed with ALS were utilized in each dosage cohort (three or four receiving AEOL 10150 and one receiving placebo). Each dose cohort was evaluated at a separate clinical center. In total, seven separate cohorts were evaluated for the study, and 25 ALS patients received AEOL 10150.

Based upon an analysis of the data, it was concluded that single doses of AEOL 10150 ranging from 3 mg to 75 mg were well-tolerated. In addition, no serious adverse clinical events were reported, nor were there any significant laboratory abnormalities.