AEOL 10150

Description: Double-Blind, Randomized, Placebo-Controlled, Phase I, Multiple Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Aeolus 10150 Administered By Subcutaneous Injection in Patients with Amyotrophic Lateral Sclerosis

This study is expected to start in late 2005 or early 2006. This is a Phase I study, looking at the safety of a novel compound, AEOL 10150, which acts catalytically to destroy superoxide, hydrogen peroxide and peroxynitrite, and to inhibit lipid peroxidation. Administration of AEOL 0150, beginning at symptom onset, slows the progression of motor neuron disease and extends survival in the G93A SOD1 transgenic mouse model of ALS.

The primary objective of this study is to evaluate the safety and tolerability of multiple doses of AEOL 10150 at each of three separate dosage levels in patients with ALS. The secondary objectives are to establish the multiple dose pharmacokinetic profile of AEOL 10150 and to select, based on these multiple dose safety and pharmacokinetic data, dosage regimens to be evaluated in subsequent Phase II studies aimed at evaluating the efficacy of AEOL 10150. Two specific eligibility requirements are the ability to stand independently for 3 minutes, and the ability to eat solid food. There will be one screening visit, a 9 night stay in our General Clinical Research Center, and one follow-up visit at our center.

For further information, please contact Kate Bednarz: keb2114@columbia.edu and phone number (212) 305-2027

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