Topline Results of Phase III Study in Acute Ischemic Stroke (Dias-2) Do Not Demonstrate Difference Between Desmoteplase and Plac
May 31 2007 - 5:15PM
PR Newswire (US)
NEW YORK, May 31 /PRNewswire-FirstCall/ -- Forest Laboratories,
Inc. (NYSE:FRX) and PAION AG (Aachen, Germany -- Frankfurt Stock
Exchange, Prime Standard: PA8) 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. (Logo:
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO ) 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, 9 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. Forest will
review the complete study database over the coming weeks to
determine the appropriate next steps and its role regarding U.S.
development of desmoteplase. The headline results of the DIAS-2
study will be presented on 1 June 2007 at 10:45 a.m. BST within the
"Large Clinical Trials II" session at the XVI European Stroke
Conference in Glasgow, Scotland, U.K. PAION will host a conference
call on 1 June 2007 to discuss the DIAS-2 headline results starting
at 1:00 p.m. BST (02:00 p.m. CEST, 08:00 a.m. EDT). To access the
call please dial +44 20 7138 0819 UK, +49 69 9897 2634 Germany, +1
718 354 1361 USA. Title: "PAION DIAS-2 results" A replay of the
call will be available until end of June 5, 2007, at +44 20 7806
1970 UK, +49 69 22222 0418 Germany, +1 718 354 1112 USA, Replay
Passcode: 4318989# In addition, a webcast of the conference call
(listen-only mode) will be accessible through a link provided on
PAION's corporate website at http://www.paion.de/. About
Desmoteplase Desmoteplase, the most fibrin-specific plasminogen
activator known today, is a genetically engineered clot-dissolving
protein found in the saliva of the vampire bat Desmodus rotundus.
It has received fast-track designation from the U.S. Food and Drug
Administration for the indication of acute ischemic stroke. About
Stroke According to a recent publication by the American Stroke
Association (ASA), stroke now is the second leading cause of death
worldwide and is a leading cause of serious, long-term disability.
In the U.S. alone, 700,000 people suffer a stroke each year, and
approximately 20% die within four weeks. For the U.S., the American
Heart Association (AHA) expects the financial burden of stroke due
to in-hospital costs, long-term care programs and productivity
losses to be 63 billion dollars in 2007 alone. About Forest
Laboratories and Its Products Forest Laboratories
(http://www.frx.com/) is a U.S.-based pharmaceutical company
dedicated to identifying, developing and delivering products that
make a positive difference in peoples' lives. Forest Laboratories'
growing product line includes Lexapro(R) (escitalopram oxalate), an
SSRI indicated for adults for the initial and maintenance treatment
of major depressive disorder and generalized anxiety disorder;
Namenda(R) (memantine HCl), an N-methyl D- aspartate
(NMDA)-receptor antagonist indicated for the treatment of moderate
to severe Alzheimer's disease; Benicar(R)* (olmesartan medoxomil),
an angiotensin receptor blocker, and Benicar* HCT(R) (olmesartan
medoxomil- hydrochlorothiazide), an angiotensin receptor blocker
and diuretic combination product, each indicated for the treatment
of hypertension; and Campral(R)* (acamprosate calcium), indicated
in combination with psychosocial support for the maintenance of
abstinence from alcohol in patients with alcohol dependence who are
abstinent at treatment initiation. *Benicar is a registered
trademark of Daiichi Sankyo, Inc., and Campral is a registered
trademark of Merck Sante s.a.s., subsidiary of Merck KGaA,
Darmstadt, Germany. Except for the historical information contained
herein, this release contains "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of
1995. These statements involve a number of risks and uncertainties,
including the difficulty of predicting FDA approvals, the
acceptance and demand for new pharmaceutical products, the impact
of competitive products and pricing, the timely development and
launch of new products, and the risk factors listed from time to
time in the Forest Laboratories' SEC reports, including the
Company's Annual Report on Form 10-K for the fiscal year ended
March 31, 2007.
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO
http://photoarchive.ap.org/ DATASOURCE: Forest Laboratories, Inc.
CONTACT: Charles E. Triano, Vice President - Investor Relations of
Forest Laboratories, Inc., +1-212-224-6714, Web site:
http://www.frx.com/
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