Ad hoc: PAION AG: PAION AG: Topline results of Phase III study in acute ischemic stroke
(DIAS-2) do not demonstrate difference between desmoteplase and
placebo
Aachen (Germany), May 31st, 2007 - PAION AG (Frankfurt Stock
Exchange, Prime Standard: PA8) and its US partner Forest
Laboratories, Inc. (NYSE: FRX) 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 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 responders. Patients defined as
responders by such criteria are in general able to function
independently, having no or few deficits.
Improvement of clinical outcome was found with 47.4% of patients
treated with 90 mcg/kg Desmoteplase and 36.4% of patients treated
with 125 mcg/kg Desmoteplase, compared to 46.0% in the placebo group
with neither dose of Desmoteplase statistically significantly
different compared to placebo.
The rate of symptomatic intracranial bleeding within 72 hours after
study drug administration was 0% in the placebo group, 3.5% in the
90 mcg/kg dose group and 4.5% in the 125 mcg/kg group. There were
four patient deaths reported in the placebo group, three reported in
the 90 mcg/kg dose group and 14 reported in the 125 mcg/kg dose group
within the 90 day follow-up period. Ten of the 14 deaths in the
125 mcg/kg dose group were considered by the investigators as not
related to the drug, nine of which occurred 14 or more days after
stroke and were from non-neurological causes.
These data are surprising and are not consistent with previously
observed patterns in the DIAS/DEDAS trials and larger size,
placebo-controlled acute stroke trials. The absence of consistency
with previous findings is not easy to explain, but in-depth analyses
are planned to better understand the data.
Contact
Dr. Peer Nils Schröder, Investor Relations / Public Relations
PAION AG
Martinstrasse 10-12, 52062 Aachen - Germany
Tel. +49 241 4453 152
E-mail pn.schroeder@paion.de
www.paion.de
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PAION AG
Martinstrasse 10 - 12 Aachen Germany
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