Aeolus Pharmaceuticals Announces Initiation Of Multiple Dose Study Of AEOL 10150 In A Patient With ALS

Main Category: Muscular Dystrophy / ALS
Article Date: 02 Oct 2008 - 1:00 PDT

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Aeolus Pharmaceuticals, Inc. (OTCBB: AOLS) announced today that it has initiated a follow-on Phase I open label compassionate use multiple dose study of AEOL 10150 in a patient diagnosed with progressive and debilitating amyotrophic lateral sclerosis, also referred to as ALS or Lou Gehrig's disease. The study is being conducted at UCLA by Martina Wiedau-Pazos, M.D., and is designed to evaluate the safety and efficacy of AEOL 10150 in an ALS patient over an extended period of time. The patient will receive a subcutaneous injection of 75mg of AEOL 10150 two times each day for up to 24 weeks. Efficacy and safety data will be monitored in real-time for the duration of the study. The primary objective of this study is to assess the clinical efficacy of AEOL 10150 with respect to the patient's baseline assessment of functional status. Secondary objectives include the assessments of muscle strength, respiratory function, quality of life and safety.

The new study will build on results from a phase 1 single dose study and phase 1, 6 ½ day study already completed in patients with ALS. In the single dose study, all six single doses (3, 12, 30, 45, 60 and 75 mg) were well tolerated with no serious adverse events, no significant laboratory abnormalities and no cardiovascular issues related to AEOL 10150. The results of the phase 1 multiple dose study showed that AEOL 10150 at doses up to 2 mg/kg/day were safe and well tolerated with an excellent pharmacokinetic profile in ALS subjects.

"We are excited to get this study running, as it will provide the Company with important longer-term safety data for AEOL 10150, which will be useful for future potential development in both ALS and radiation therapy," stated John L. McManus, President and Chief Executive Officer of Aeolus Pharmaceuticals, Inc. "We are grateful to Dr. Wiedau-Pazos for her participation in this program, and the hope that it may provide to ALS patients. We also appreciate the contributions of Symbion Research International, Inc., whose collaboration was instrumental in the design and initiation of this study."

"The entire Symbion team is very excited that this study has begun," said Peggy Pence, Ph.D., President and Chief Executive Officer of Symbion Research International, Inc. "We consider it our privilege to participate in this study that provides hope to this patient and also has the potential to advance the future treatment of all ALS patients."

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 mimics and thereby amplifies the body's natural enzymatic systems for eliminating reactive oxygen species, or free radicals. Studies funded by the National Institutes for Health are currently underway evaluating AEOL 10150 as a treatment for exposure to mustard gas. Additionally, the Company has plans to initiate animal studies necessary to seek approval of the compound as a treatment to protect the lungs from exposure to radiation. http://www.aeoluspharma.com

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' Annual Report on Form 10-K for the year ended September 30, 2007. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.

Aeolus Pharmaceuticals