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Aeolus says last cohort in phase 1 multi-dose study of AEOL 10150 will begin testing this month
By Jennifer Lanning Drey
Eugene, Ore., Aug. 24 - Aeolus Pharmaceuticals, Inc. expects to begin treating the last cohort of its phase 1 multi-dose study of AEOL 10150 in patients with amyotrophic lateral sclerosis or Lou Gehrig's disease this month, Richard P. Burgoon Jr., Aeolus' chief executive officer, told investors during a presentation Thursday.
The six patients in the final cohort will be given a 2 mg per kg continuous infusion pump, and the test should be complete by October, Burgoon said.
Aeolus has already completed the first two cohorts of the study, which tested AEOL 10150 at 80 mg and 120 mg per day doses. Patients in both cohorts demonstrated no serious or clinically significant adverse events.
Following the conclusion of the third cohort in the multi-dose study, Aeolus will look to start a phase 2 multi-dose study in 2007, Burgoon said.
Aeolus has already completed long-term toxicology studies of AEOL 10150, which included a 39-week study of the drug in primates, a 26-week study in rodents and a four-week washout rodent study.
"That allows us to be able to have a little bit more of a robust opportunity in our phase 2 clinical testing of the compound," Burgoon said.
Aeolus believes AEOL 10150 is the first catalytic antioxidant to avoid the safety problems experienced with other compounds in its class, he said.
The company also believes there may be therapeutic opportunities for AEOL 10150 in central nervous system diseases, including Parkinson's disease and oncology, Burgoon told investors.
Based in Laguna Niguel, Calif., Aeolus develops therapeutic agents based on its small molecule catalytic antioxidants for neurodegenerative and other neurological disorders as well as radiation oncology.
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