AstraZeneca's NXY-059 performs well in study

Results of the SAINT 1 (Stroke Acute Ischemic NXY-059 Treatment) study, which were published in the New England Journal of Medicine, demonstrate the Anglo-Swedish major AstraZeneca's investigational drug NXY-059 shows efficacy when used in the treatment of ischemic stroke. Analysis of the data showed a statistically-significant reduction in the debilitating consequences of the condition, when measured using the Modified Rankin Scale.

The study, which was conducted at approximately 158 research centers worldwide, was a double-blind, placebo-controlled assessment in which patients were randomized to receive the drug or placebo within six hours of an acute ischemic stroke event. Analysis of the findings revealed that clinical benefit from the drug was seen after seven days, and that this persisted through the remainder of the 90-day assessment. The researchers added that the efficacy of the treatment was not affected by the time of drug administration post AIS, or by the event's severity.

The drug did not bring about any improvement in neurologic function, and the effect on mortality did not differ from placebo. Adverse events included fever, constipation, headache, urinary tract infection and hypokalemia. In addition, the incidence of intracranial hemorrage was higher in patients treated with NXY-059 and the tissue plasminogen activator alteplase than in the placebo and alteplase treated cohort.