NXY-059 for the Treatment of Acute Ischemic Stroke

Two phase 3 clinical trials (SAINT I and SAINT II) evaluated the free-radical–trapping agent NXY-059 for the treatment of acute ischemic stroke. The SAINT I trial, reported last year, suggested that NXY-059 might be effective. The authors now report the results of the SAINT II trial, which clearly shows that NXY-059 is not effective for ischemic stroke. The discrepancy in the findings of the two trials is best explained by chance false positive findings in the SAINT I trial. The authors report the results of the SAINT II trial, which clearly shows that the free-radical–trapping agent NXY-059 is not effective for ischemic stroke. Currently, thrombolysis with alteplase (tissue plasminogen activator [rt-PA]) is the only widely approved treatment for acute stroke, and it is underused. There is an urgent need for new therapies that are safer and can be offered to a higher percentage of patients. Cerebral tissue can be protected in animal models by a variety of agents that attenuate neuronal injury after ischemia, 1 but none of these putative neuroprotectants have been confirmed as an effective therapy in clinical trials. NXY-059, a free-radical–trapping agent, has been extensively tested in animal models of focal ischemic stroke and has been shown to improve functional recovery . . .