Cerestat Promising In Phase II; Pivotal Trials Planned

Cambridge Neurosciences has reported that its NMDA receptor ion channel blocker Cerestat (aptiganel) has shown evidence of clinical benefit in a Phase II study in acute ischemic stroke patients. On the basis of these data, and the results of two other studies, Cambridge and partner Boehringer Ingelheim have decided to press on with a pivotal study of aptiganel in 900 patients.

Preliminary data from the Phase II study were presented at the American Academy of Neurology meeting in San Francisco on March 28 by Keith Edwards, a neurologist at the Southwestern Vermont Medical Center.

The 90-day Phase II study enrolled 132 patients at 30 centers across the USA and Europe. The primary measure of outcome was the National Institutes of Health Stroke scale, while secondary measures included assessments of function, such as the Rankin Scale and Barthel Index of daily living activities. Patients were randomized to receive either placebo or one of three dose regimens; Cerestat 30, 70 or 110mcg/kg by bolus and infusion over a four-hour period.