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Adeona Executes Agreement to Initiate Phase IIb Clinical Trial of Proprietary Zinc-Based Therapy in Lou Gehrig's Disease (ALS)
Date:6/23/2011

let, and AEN-200, a copper tablet.

The planned co-primary endpoints are: 1) determining the safety of AEN-100 (elemental zinc) at 150 mg (two 75mg tablets) given to patients once daily with ALS by assessing adverse events and measuring zinc and copper levels every three months; and 2) determining the efficacy of AEN-100 by assessing the rate of disease progression as measured by the ALSFRS-R, a revised ALS functional rating scale that incorporates assessments of respiratory function.

The planned secondary endpoints are: 1) measuring levels of beta-methylamino-L-alanine (BMAA) in blood and urine to determine if there is a decline in these levels over the course of treatment; 2) following disease progression as measured by Forced Vital Capacity (FVC), a measurement of lung function that has been shown to correlate with disease survival; and 3) following progression of muscle weakness through quantitative strength measurements using hand-held dynamometry.

Ongoing Phase I/II Open Label Safety Study of Zinc Therapy in ALS Patients

Currently the clinical investigators at the PNA Center for Neurological Research are conducting a Phase I/II open label study of zinc therapy in ALS patients to determine the safety of zinc in conjunction with low doses of copper. To date, no safety issues related to zinc therapy have been observed in the ALS patients.

Potential Benefit of Zinc Therapy in ALS Patients

The clinical investigators at the PNA Center for Neurological Research cite multiple lines of scientific research that suggest a potential benefit of zinc therapy for ALS patients, including:

  • During the 1950's, an epidemic of ALS was discovered on the island of Guam and the Trust Territories of the Pacific that revealed a form of ALS that was 100 times more prevalent than in the rest of the world.

  • Research on this cluster of AL
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SOURCE Adeona Pharmaceuticals, Inc.
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