SAN DIEGO, Dec. 8 /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 results from its Phase I single dose study of AEOL 10150 in patients with amyotrophic lateral sclerosis will be presented today by Dr. Robert G. Miller, Professor, UCSF Department of Neurology, California Pacific Medical Center, at the 16th International Symposium on ALS/MND, Dublin, Republic of Ireland. Amyotrophic lateral sclerosis is also referred to as ALS or Lou Gehrig’s disease.
The presentation, entitled “Safety, tolerability and pharmacokinetics of AEOL 10150 in ALS” includes as co-authors the Principal Investigators from the single-dose study (Drs. Miller, Cudkowicz, Gordon, Heiman-Patterson, Maragakis, Mitsumoto and Shefner) all of whom specialize in the clinical treatment of ALS.
As noted in the presentation abstract, “The study was designed to evaluate six single doses of AEOL 10150 (3, 12, 30, 45, 60 and 75 mg) ... a total of 33 patients were enrolled at five sites ... Single doses of AEOL 10150 were administered in a blinded manner subcutaneously to 4-5 patients in each dosing cohort, while one patient received placebo [in each cohort]. Patients were monitored with frequent clinical, neurologic, and laboratory evaluations, as well as extensive cardiopulmonary monitoring (including frequent vital signs, electrocardiograms, and extended Holter monitoring) ....Adverse events were recorded.” The study co-authors further noted that, “Single doses of AEOL 10150 were well tolerated. Adverse events were primarily mild in severity (injection site discoloration and stinging). There were no serious adverse events attributable to[AEOL 10150].”
Based upon the results developed from the study, the co-authors concluded that, “Single doses of AEOL 10150 up to 75 mg were safe and well tolerated in ALS patients. Cardiovascular abnormalities observed in animal toxicology studies were not observed in ALS patients. The pharmacokinetic profile suggested implementation of twice a day dosing for three dosing cohorts (40, 60 and 75 mg) in the multi-center, multiple dose Phase I study, which has been initiated.” Details about the Multiple Dose Study are provided below.
About the Multiple Dose Study of AEOL 10150.
On November 30, 2005, Aeolus announced preliminary safety results from the first cohort of the multiple dose study of AEOL 10150 in ALS patients. As announced, the first cohort (40 mg AEOL 10150; 80 mg total per day) has been completed, the second cohort (60 mg; 120 mg total per day) has been initiated, and the data analysis from the second cohort is anticipated to be completed before the end of this year. The third and final cohort (75 mg; 150 mg total per day) is expected to begin and be completed in January 2006. Human- efficacious dose modeling, based upon use of AEOL 10150 in an accepted model of ALS, suggests that the estimated effective dose of AEOL 10150 in ALS patients (based on a 132 pound human) should be about 12 mg per day.
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 injection 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 60 mg (i.e., 120 mg/kg daily for six days and 60 mg on the seventh day). In the third cohort, each injection will be 75 mg (i.e., 150 mg daily for six days and 75 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 patented, 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 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.
Aeolus Pharmaceuticals
CONTACT: Richard P. Burgoon, Jr., Chief Executive Officer of AeolusPharmaceuticals, Inc., +1-949-481-9825
Web site: http://www.aeoluspharma.com/
