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Topline Results of Phase III Study in Acute Ischemic Stroke,(Dias-2) Do Not Demonstrate Difference Between Desmoteplase and,Placebo

NEW YORK, May 31, 2007 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. and PAION AG today announced topline results of the DIAS-2 (Desmoteplase In Acute Ischemic Stroke) study with the compound Desmoteplase. The Phase III study was designed to investigate the improvement of clinical outcome in patients with acute ischemic stroke treated with Desmoteplase within 3 to 9 hours after onset of stroke symptoms as compared to placebo. The primary efficacy endpoint (difference between active treatment and placebo in percentage of composite responders as defined below) was not met. The blinded, randomized, placebo-controlled, dose-ranging trial was jointly conducted by PAION and Forest Laboratories, Inc., and enrolled a total of 186 patients in Europe, USA, Canada, Australia, Hong Kong and Singapore. Forest Laboratories, Inc. is the partner of PAION for Desmoteplase for North America and H. Lundbeck A/S is PAION's partner for the rest of the world.

In this study, patients received either placebo (N=63), 90 mcg/kg (N=57), or 125 mcg/kg (N=66) of Desmoteplase as an intravenous bolus within 3-9 hours after the onset of stroke. Patients were eligible for treatment only in case of a distinct penumbra of at least 20% (insufficiently perfused but still salvageable tissue area around the primary location of stroke), which was confirmed by magnetic resonance imaging (MRI) or perfusion computed tomography (pCT).

The primary efficacy endpoint in the study was clinical improvement at Day 90 defined for each patient as achievement of all three of the following criteria; (1): Improvement of greater than or equal to 8 points from baseline on the National Institutes of Health Stroke Scale (NIHSS) or NIHSS score less than or equal to 1, (2): Modified Rankin Scale (MRS) score of 0-2, and (3): Barthel Index (BI) score of 75-100. Only patients who simultaneously met the criteria along all three scales were considered resp
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