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Arundic Acid Has Neuroprotective Potential For Treating Ischaemic Stroke: Presented at ANA

By Paula Moyer

TORONTO, ON -- October 11, 2004 -- The investigative agent arundic acid is showing potential as a neuroprotective agent for treating patients after ischaemic stroke, according to investigators.

Presenting study findings here October 5^th at the 129^th annual meeting of the American Neurological Association, L. Creed Pettigrew, MD, professor of neurology at the University of Kentucky in Lexington, Kentucky, United States, said, "Arundic acid has promise in preventing brain damage after stroke." He continued, "It can be used safely with or without thrombolytics."

Dr. Pettigrew and his co-investigators were interested in arundic acid because earlier primate studies indicated that the drug was able to reach effective blood levels without increasing the risk of haemorrhage when used with thrombolytics. These criteria are the standard for a post-stroke neuroprotective agent, he said.

Therefore, they observed the results of arundic acid in 92 patients, 49 of whom received the study drug and 43 of whom received placebo within 24 hours after stroke onset. The patients in the treatment group received 2 to 12 mg/kg/hr. Patients received 8 to 9 courses of treatment for 7 days. The investigators conducted pharmacokinetic profiling on days 1 and 3. For comparison, they also studied the effects in 9 healthy volunteers. Of these, 6 received 10 mg/kg/hour of the study drug, and 3 received placebo.

The investigators assessed patients' haemostasis before treatment, at the onset of treatment, and 6 hours after treatment. The instruments used included platelet aggregation, the ratio of prothrombin time and activated partial thromboplastic time (PT/aPTT), and whole blood clotting time as calculated by the Ivy method.

The plasma level of arundic acid that was deemed therapeutic was at least 2 mg/kg per hour. This level was reached in all subjects. Fortunately, 1 hour after infusion of arundic acid, the investigators documented no effect of therapy on either cellular or humoral coagulation. Dr. Pettigrew and his co-investigators reported that they did not have to adjust the dose on any patient, although drug clearance was slightly lower in older subjects who were more than 70 years old.

The study was funded by the Ono Pharmaceutical Company.

[Presentation title: Arundic acid in acute ischemic stroke: Pharmacokinetics and coagulation effects. Abstract #125]

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