Ono2506

A novel neuroprotectant that inhibits astrocyte activation, 0N0-2506 (arundic acid), has recently been tested in several large clinical trials and has been shown to prevent delayed infarct expansion in animal models. It appears to inhibit astrocytic overexpression of S100B, to inhibit the expression of inducible nitric oxide synthase, and possibly help to restore the activity of astroglial glutamate transporters post ischemia. Several small Phase 2a acute stroke trials were completed in the United States and Japan that showed that the drug was well tolerated (Investigator's Brochure. Ono Pharmaceuticals, 2004). A 1500-patient Phase 3 trial was recently in progress in North America, with the goal to test two different doses of 0N0-2506 or placebo in patients presenting within 6 hr of stroke. Patients had to have "cortical" signs and an NIHSS

between 11 and 22. Unfortunately, the study was discontinued after a futility analysis of the first approximately 700 patients suggested that it was very unlikely that any efficacy would be found.

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