SAN DIEGO, June 20 /PRNewswire-FirstCall/ -- Aeolus Pharmaceuticals, Inc. , a developer of a new class of disease-modifying compounds with potent activity in pre-clinical models of central nervous system diseases and oncology, announced today that it has selected AEOL 11207 as its first development candidate from its Pipeline Initiative. Because of the wide-ranging therapeutic opportunities that the Aeolus compounds evidence in diverse pre-clinical models of human diseases, the Company has not yet ascertained what the most robust therapeutic use of AEOL 11207 might be. However, data developed to date suggest that AEOL 11207 may be useful as a potential once-every-other-day oral therapeutic treatment option for CNS disorders, most likely Parkinson’s disease. Two other Aeolus compounds from its Pipeline Initiative, AEOL 11203 and AEOL 11216, are currently being evaluated and considered for non-CNS indications, and these compounds are also orally bioavailable.
AEOL 10207 in Parkinson’s disease
A biological hallmark of Parkinson’s disease is a reduction in brain dopamine levels. Preventing or slowing the destruction of brain cells that lead to the depletion of dopamine levels in the brain is an important therapeutic approach for the treatment of this disease.
Preliminary data developed by scientists from Aeolus and the Department of Pharmaceutical Sciences, University of Colorado Health Sciences Center and Department of Medicine, indicate that when administered orally, AEOL 11207 is greater than 80% bioavailable, meaning that it is readily absorbed and reaches both the circulatory system and the brain in sufficient amounts to demonstrate biological activity. Data developed with AEOL 11207 in a widely used animal model of Parkinson’s disease (the “MPTP model”) showed that when administered orally, AEOL 11207 crosses the blood brain barrier and protected dopamine neurons in a dose-dependent manner. Further data suggest that the compound has a half life (a measurement of the time period for which a compound stays in the body) of about 3 days in both the circulatory system and the brain, and that prior to stopping administration of the compound, the levels of AEOL 11207 in both the circulatory system and brain reach a steady state (a valuable measurement of when the levels of the drug in the body remain substantially constant, neither increasing nor decreasing) after 2 days of dosing. Data have also been developed that indicate that when dosing of AEOL 11207 is stopped, the compound is excreted from the body.
For this and other reasons, the Company believes that the therapeutic rationale for developing AEOL 11207 as a neuroprotectant, may substantially change the course of therapeutic treatment options for Parkinson’s disease if AEOL 11207 were to achieve regulatory approval for commercialization. The Company notes that it can not at this time assume that such regulatory approval for AEOL 11207 can be or will be secured.
AEOL 11207, AEOL 11203 and AEOL 11216, as with all of the Aeolus compounds, are patent-protected and have the same chemical core structure as AEOL 10150. 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 decrease reactive oxygen (ROS) and reactive nitrogen species (RNS), all of which are implicated in a variety of central nervous system diseases.
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 March 31, 2006. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Please visit our website at www.aeoluspharma.com.
Aeolus Pharmaceuticals, Inc.
CONTACT: Richard P. Burgoon, Jr., Chief Executive Officer of AeolusPharmaceuticals, Inc., +1-949-481-9825
Web site: http://www.aeoluspharma.com/
