The SAINT I ( Stroke Acute Ischemic NXY-059 Treatment ) trial, published in the New England Journal of Medicine, has shown that NXY-059 is a promising drug for the treatment of acute ischemic stroke.

The data showed a statistically significant reduction with NXY-059 versus placebo on the primary outcome of stroke-related disability, as assessed on the Modified Rankin Scale ( mRS ) ( p=0.038 at 90 days ).

Additional analysis of the data showed a reduction in the disability of patients at both ends of the scale, with 4.4 percent more patients treated with NXY-059 becoming free of symptoms ( mRS 0 vs. mRS > 0; p=0.003 ) and 3.7 percent more patients able to walk without help and being less dependent on others for bodily needs ( mRS less than or equal to 3 vs. mRS >3; p=0.02 ), compared to placebo.

SAINT I was a double blind, placebo-controlled phase III study, in which patients were randomized to receive NXY-059 or placebo within six hours of acute ischemic stroke. The study involved 1,722 patients in 158 centers from 24 countries.

Clinical benefit was seen at the earliest time point assessed ( 7 days ), and persisted through the end of the study ( 90 days ).
The treatment effects were not affected by the time to treatment, the severity of stroke, or use of thrombolysis.

Kennedy Lees, principal investigator and at the University of Glasgow, UK, commented, " This is an exciting result. A treatment confirmed to reduce disability in such a wide range of stroke patients could have a profound effect on the number of families that are devastated by stroke. For a condition that carries a worse prognosis than most forms of cancer, the development of a completely new approach to treatment would be a fantastic achievement."

NXY-059 did not significantly improve neurologic function as measured on the National Institutes of Health stroke scale ( NIHSS ).
Mortality was unaltered by treatment with NXY-059 compared with placebo.
The most common adverse events for NXY-059 in the study were fever ( 19 vs. 19.2 percent for NXY-059 and placebo, respectively ), constipation ( 9.8 vs. 11.7 percent ), headache ( 9.6 vs. 9.7 percent ), urinary tract infection ( 8.9 vs. 6.8 percent ), stroke in evolution ( 6.5 versus 8.1 percent ) and hypokalemia ( 6.4 vs. 4.4 percent ).

The incidence of symptomatic intracranial hemorrhage in patients treated with NXY-059 and Alteplase, a tissue plasminogen activator ( rt-PA ), was lower than in patients treated with placebo and rt-PA ( 2.5 percent vs. 6.4 percent, p=0.036, post-hoc analysis ).

Source: The New England Journal Medicine, 2006


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