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March 19, 2003 In mouse models of amyotrophic lateral sclerosis (ALS, Lou Gehrig disease), vaccination with glatiramer acetate protected against the degeneration of the motor neurons (movement nerves) responsible for its symptoms. Glatiramer acetate is sold as Teva’s (NASDAQ: TEVA) Copaxone, currently approved for reduction of the frequency of relapses in patients with relapsing-remitting multiple sclerosis. Aventis (NYSE: AVE) has also developed an oral glatiramer acetate formulation. The data presented in this and other publications suggest that glatiramer is likely to demonstrate a therapeutic effect in clinical trial development for the management of peripheral nerve disorders.
Evidence that glatiramer acetate activates self-reactive T cells was published. Self-reactive T cells have been recently demonstrated to be protective in acute neurodegenerative conditions. Dr. Michal Schwartz (Weizmann Institute of Science, Rehovot, Israel) and colleagues had previously shown that “(glatiramer) vaccination was found to bypass the tissue-specificity barrier imposed by antigens residing in the damaged tissue and to significantly increase neuronal survival,” and now they have begun to assess glatiramer’s effects in mice overexpressing the defective human superoxide dismutase gene (SOD1) associated with ALS development.
Mice were immunized at 60 days of age with glatiramer followed by daily oral galtiramer. These mice survived for a mean of 263 days versus 211 days for control mice (p < 0.0001). Onset of disease was also significantly delayed.
The team is also investigating non-SOD mutation-related motor neuron death, and has generated compelling preclinical efficacy data. The team concludes that Copaxone, perhaps with modified chemistry, “should immediately be developed into a vaccine for the treatment of peripheral nerve injury and motor neuron diseases.”
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