SAN DIEGO , Sept. 20 /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 that data developed
in conjunction with the laboratory of
The studies, entitled, 'A Lipophilic Metalloporphyrin Catalytic Antioxidant Ameliorates MPTP Neurotoxicity' and 'Attentuation of MPTP Neurotoxicity by a Lipophilic Metalloporphyrin Catalytic Antioxidant,' provide initial data derived from subcutaneous administration of AEOL 11207 in a scientifically accepted animal model of Parkinson's disease, known as the mouse MPTP model of Parkinsonism.
A biological hallmark of Parkinson's disease is a reduction in brain
dopamine levels. Thus, preventing the depletion of dopamine levels in the
brain is an important therapeutic approach for the treatment of the disease.
The data developed by
AEOL 11207, as with all of the Aeolus compounds, has the same chemical core structure as AEOL 10150. AEOL 10150 is currently undergoing human clinical evaluation. Because of this common structural feature, it is anticipated that the Aeolus compounds that are selected for clinical evaluation from the Pipeline Initiative will evidence substantially the same safety profile in human clinical evaluations as seen with AEOL 10150, making clinical trial design and testing of the Aeolus compounds more robust and facile. Furthermore, all of the Aeolus compounds evidence the ability to scavenge and reduce reactive oxygen and nitrogen species, as well as hydrogen peroxide production, all of which being implicated in a variety of central nervous system diseases and disorders.
About Parkinson's Disease and the MPTP Animal Model
Parkinson's disease is a common neurodegenerative disorder, second in frequency only to Alzheimer's disease. The role of free radicals is strongly implicated in this disease, and scavenging reactive oxygen species is an important therapeutic avenue for the treatment of Parkinson's disease. The disease affects approximately 500,000 Americans, with an incidence ranging from 14 to 80 per 100,000. Every year about 50,000 new cases are diagnosed in the United States . The disease is found in about 1% of those older than 50 years and 3% of those aged 95 or greater. Symptoms of this disease include tremors, rigidity, and bradykinesia (i.e. slowness of movement). In the more advanced stages, it can cause fluctuations in motor function, sleep problems, and various neuro-psychiatric disorders. According to the National Parkinson Foundation, each patient spends an average of $2,500 a year for medications. After factoring in office visits, Social Security payments, nursing home expenditures, and lost income, the total cost to the Nation is estimated to exceed $5.6 billion annually.
Parkinson's specifically involves the progressive destruction of the nerves that secrete dopamine and control the basal ganglia, an area of the brain involved in the regulation of movement. Dopamine turnover has been shown to elevate the levels of reactive oxygen species (ROS) in the brain. In addition, a street-drug contaminant has appeared that can cause parkinsonism in drug abusers. The compound N-methyl-4-phenyl-1, 2, 3, 6-tetrahydropyridine, or 'MPTP,' has been identified in underground laboratory preparations of a potent analog of meperidine (Demerol(TM)). MPTP-containing powder, sometimes sold as a new 'synthetic heroin,' can be dissolved in water and administered intravenously or taken by the intranasal route. Agents such as MPTP overproduce ROS in the basal ganglia. MPTP has been documented to produce irreversible chronic parkinson symptoms in drug abusers, and, as noted above, the MPTP animal model is accepted by scientists as a model of the human version of this disease. Because ROS mediated neuronal dysfunction may play a key role in the development of Parkinson's disease, the applicability of the Aeolus compounds for this type of disease is based in part upon the ability of the compounds to scavenge ROS.
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. On September 7, 2005 , Aeolus announced the results of its Phase 1 single dose study of AEOL 10150 in 25 ALS patients. 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.
The statements in this press release that are not purely statements of historical fact are forward-looking statements. Such statements include, but are not limited to, those relating to Aeolus' product candidates, as well as its proprietary technologies and research programs. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Aeolus' actual results to be materially different from historical results or from any results expressed or implied by such forward- looking statements. Important factors that could cause results to differ include risks associated with uncertainties of progress and timing of clinical trials, scientific research and product development activities, difficulties or delays in development, testing, obtaining regulatory approval, the need to obtain funding for pre-clinical and clinical trials and operations, the scope and validity of intellectual property protection for Aeolus' product candidates, proprietary technologies and their uses, and competition from other biopharmaceutical companies. Certain of these factors and others are more fully described in Aeolus' filings with the Securities and Exchange Commission, including, but not limited to, Aeolus' Quarterly Report on Form 10-Q for the quarter ended June 30, 2005 . Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.
SOURCE Aeolus Pharmaceuticals, Inc.
