SAN DIEGO, Sept. 7 /PRNewswire-FirstCall/ -- Aeolus Pharmaceuticals, Inc.
(OTC Bulletin Board: AOLS.OB), a developer of a potential new class of
disease-modifying compounds that have evidenced efficacy in pre-clinical
models of central nervous system diseases, today announced results for its
multi-center, double-blind, randomized, placebo-controlled, Phase 1 clinical
trial. This escalating single dose study was conducted to evaluate the
safety, tolerability and pharmacokinetics of AEOL 10150 administered by
subcutaneous injection in patients with amyotrophic lateral sclerosis (ALS or
Lou Gehrig's disease).

"We are very pleased with the results from our Phase 1 single dose study
of AEOL 10150 and we are looking forward to moving this exciting and potential
therapeutic into multiple dose evaluation," noted Richard P. Burgoon, Jr.,
Aeolus' chief executive officer. Mr. Burgoon further stated that "Although
the Phase 1 single and multiple dose studies are being conducted in patients
diagnosed with ALS, these Phase 1 safety studies can also support human
efficacy studies of AEOL 10150 in other clinical indications for which AEOL
10150 has shown pre-clinical efficacy." On this point, Mr. Burgoon noted that
in addition to efficacy in the scientifically recognized ALS model, AEOL 10150
also has demonstrated efficacy in models of other neurodegenerative disorders,
autoimmune diabetes, stroke, chronic obstructive pulmonary disease, pancreatic
islet cell preservation, radiation-induced lung fibrosis, and inflammation.

Phase 1 Single Dose Clinical Trial Details

In the study, 4-5 patients diagnosed with ALS were utilized in each dosage
cohort (3 or 4 receiving AEOL 10150 and 1 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. Based upon extensive cardiovascular monitoring (i.e.
frequent electrocardiograms and continuous Holter recordings for up to 48
hours following dosing), there were no compound-related cardiovascular
abnormalities.

Following administration of single doses of AEOL 10150 (3, 12, 30, 45, 60
and 75 mg), pharmacokinetic analysis demonstrated plasma area under the curve
(AUC) values ranging from 354 ng-hr/mL in the 3 mg group to 12,167 ng-hr/mL in
the 75 mg group. Correspondingly, Cmax ranged from 114.8 ng/mL to 1584 ng/mL,
and Tmax ranged from 1 to 2 hours in these same groups. The mean half-life of
AEOL 10150 ranged from 2.6 (3 mg cohort) to 6.4 hours (75 mg cohort). Linear
dose response, and dose proportionality, were documented. A summary of these
results is provided below in table form below.

The most frequently reported adverse events were injection site reactions,
followed by dizziness and headache. Adverse events were primarily mild in
severity, and approximately one-half of the events were considered to have a
possible relationship to the study medication. In addition, no clinically
meaningful findings were noted in the safety, laboratory, vital sign, UPDRS,
functional ALS, or ECG data. All cohorts exhibited dose-related peak plasma
drug concentrations and consistent disappearance half-lives.

Taken together, the pharmacokinetic data indicate that accumulation of
AEOL 10150 with multiple dosing is unlikely.

Launch of Phase 1 Multi-dose Clinical Trial

Based on these data, and in consultation with the Phase 1 single dose
principal investigators, Aeolus will initiate a multiple dose study of AEOL
10150 in patients diagnosed with ALS in the fourth quarter of this year. The
dosing study is expected to be completed in the fourth quarter of this year.

Under the multiple dose protocol, three groups of six ALS patients (four
receiving AEOL 10150; two receiving placebo, 18 total patients) will be
recruited, based upon patients who meet the El Escorial criteria for
Clinically Definite ALS, Clinically Probable ALS, Clinically Probably-
Laboratory-Supported ALS, or Definite Familial-Laboratory Supported ALS (i.e.,
Clinically Possible ALS with an identified SOD gene mutation). Each patient
will receive twice daily subcutaneous injections of AEOL 10150 or placebo for
six days, followed by a single subcutaneous administration on the seventh day,
for a total of 13 injections. In the first cohort, each injection will be 40
mg (i.e., 80 mg daily for six days and 40 mg on the seventh day). In the
second cohort, each injection will be 70 mg (i.e., 140 mg daily for six days
and 70 mg on the seventh day). In the third cohort, each injection will be
100 mg (i.e., 200 mg daily for six days and 100 mg on the seventh day). Each
patient will complete follow-up evaluation by 14 days.

The study is planned to be conducted at six clinical ALS centers, with
each center enrolling three patients. Male and female ALS patients, 18 to 70
years of age, will be eligible for study participation. Patients must be
ambulatory (with the use of a walker or cane, if needed) and capable of
orthostatic blood pressure assessments. Clinical signs/symptoms, laboratory
values, cardiac assessments, and pharmacokinetics (PK) will be performed.

About Aeolus Pharmaceuticals.

Aeolus is developing a variety of therapeutic agents based on its
proprietary small molecule catalytic antioxidants, with AEOL 10150 being the
first to enter human clinical evaluation. AEOL 10150 is a small molecule
catalytic antioxidant that has shown the ability to scavenge a broad range of
reactive oxygen species, or free radicals. As a catalytic antioxidant, AEOL
10150 mimics and thereby amplifies the body's natural enzymatic systems for
eliminating these damaging compounds. Because oxygen-derived free radicals
are believed to have an important role in the pathogenesis of many diseases,
Aeolus' catalytic antioxidants are believed to have a broad range of potential
therapeutic uses. The Aeolus Pipeline Initiative, begun in the third calendar
quarter of this year, is an internal development initiative focused on
advancing, in addition to AEOL 10150, several of the most promising catalytic
antioxidant compounds from Aeolus' proprietary library of 200 compounds. The
initial therapeutic focus areas for the Aeolus Pipeline Initiative are:
Parkinson's disease; Autoimmune disorders (arthritis and ulcerative colitis);
Chronic Obstructive Lung Disease; Biodefense/Radioprotection; Tumor
Suppression/Bone Marrow Transplantation; and Stroke. These therapeutic focus
areas were selected based upon preliminary data developed using Aeolus
catalytic antioxidant compounds.