Forest Laboratories Starts Confirmatory Study of Desmoteplase A Novel Investigational Treatment For Acute, Ischemic Stroke
February 09 2005 - 8:05AM
PR Newswire (US)
Forest Laboratories Starts Confirmatory Study of Desmoteplase A
Novel Investigational Treatment For Acute, Ischemic Stroke To
Confirm Expanded 9-Hour Treatment Window Seen in Two Phase II
Studies NEW YORK, Feb. 9 /PRNewswire-FirstCall/ -- Forest
Laboratories, Inc. (NYSE:FRX) today announced the initiation of a
phase IIb/III study of desmoteplase, an investigational novel
plasminogen activator, or blood clot buster, for the treatment of
acute ischemic stroke, a condition affecting over 600,000 patients
annually in the U.S. (Logo:
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO ) The DIAS2
(Desmoteplase in Acute Ischemic Stroke) study will be a multi-
center, multinational, randomized, parallel-design dose-ranging
study of more than 150 patients to confirm the results of earlier
Phase II studies that demonstrated the potential of desmoteplase to
treat acute ischemic stroke patients up to nine hours after the
onset of stroke symptoms, three times longer than the currently
available treatment allows. Because most stroke patients arrive at
the hospital outside the accepted three hour treatment window, the
majority of patients are not eligible for the currently available
treatment. Lengthening that window may expand the number of
patients who could benefit from treatment. "Preserving brain
function and restoring quality of life in patients after acute
ischemic stroke is the goal of effective stroke treatment," says
Anthony Furlan, MD, Medical Director, Cleveland Clinic Foundation
and primary investigator of the DIAS2 and DEDAS (Dose Escalation
study of Desmoteplase in Acute Ischemic Stroke) studies. "The
consistent results from two completed studies of desmoteplase in
patients with acute stroke strongly support moving forward to
further assess this potential breakthrough treatment in a large-
scale worldwide trial." Results of Desmoteplase Confirmed in Second
Phase II Study Results from the recently completed DEDAS study,
presented for the first time on February 4, 2005, as a late-breaker
presentation at the 30th International Stroke Conference in New
Orleans, Louisiana, showed trends indicating that desmoteplase
administered intravenously in the time window up to nine hours
after the onset of stroke symptoms: * Improved blood flow in the
damaged area of the brain in patients treated with 125�g/kg of
desmoteplase. * Improved clinical outcome after 90 days compared to
placebo. The DEDAS study was a multi-center, placebo-controlled,
double-blind, randomized, dose-escalation Phase II trial conducted
in 38 patients across 17 hospitals in the U.S. and three hospitals
in Europe. This study showed similar results to the earlier DIAS
(Desmoteplase in Acute Ischemic Stroke) trial, which was published
in Stroke in January 2005 and presented at the 29th International
Stroke Conference in February 2004. The former DIAS study used a
similar protocol to DEDAS, with 104 patients across 25 hospitals in
Europe, Australia and Asia. In both these studies, patients with
the potential to benefit from reperfusion therapy were selected
using MRI methods to determine whether they had salvageable tissue
and were then administered intravenous (IV) desmoteplase or placebo
in the time window up to nine hours after the onset of stroke
symptoms. Both of these studies were pilot in nature and were not
sized to show statistical differences. About Desmoteplase
Desmoteplase, first in a new class of plasminogen activators, is a
genetically engineered version of a clot-busting agent found in the
saliva of the vampire bat, Desmodus rotundus. It possesses high
fibrin selectivity, potentially allowing it to dissolve a clot
locally without adversely affecting the blood coagulation system,
possibly reducing the risk of intracranial bleeding (a common risk
when administering blood clot-dissolvers) as compared to other less
fibrin-specific plasminogen activators. Desmoteplase has received
fast-track review designation from the U.S. Food and Drug
Administration (FDA) for the treatment of acute ischemic stroke
beyond the three-hour time window. Desmoteplase was licensed to
Forest by PAION GmbH on June 30, 2004. Under the agreement, Forest
will be responsible for regulatory and sales and marketing
activities in the U.S. and Canada, and will have development and
marketing rights to other indications of the product in these
territories. PAION retains commercial rights in Europe, Japan, and
the rest of the world. About Stroke Stroke is the third leading
cause of death in the United States and Europe, behind heart
disease and cancer. According to the American Heart Association,
over 600,000 people in the U.S. fall victim to an ischemic stroke
each year, which comprises approximately 88 percent of all strokes.
The treatment of acute stroke and its serious long-term
disabilities currently present an extensive unmet need. Ischemic
stroke occurs when a blood vessel supplying the brain with oxygen
and nutrients is obstructed by a blood clot. The blockage or
rupture of the vessel results in a lack of blood flow to part of
the brain. Deprived of oxygen, nerve cells in the affected region
die within minutes or hours after the event resulting in loss of
function of the part of the body they control. Ischemic stroke
requires emergency treatment to rapidly dissolve or remove the
blood clots in the brain, but many people delay getting treatment.
The only drug currently approved for the treatment of acute
ischemic stroke, tPA (Activase(R)), must be administered within
three hours after onset of stroke symptoms, thus limiting the
potential patient population who can safely benefit from the rapid
dissolution of the blood clot and the reperfusion of blood supply
to the affected area of the brain. The majority of stroke patients
arrive at the hospital outside that treatment window. At present,
only eleven percent of ischemic stroke patients are eligible for
the treatment and fewer than four percent actually receive it.
About Forest Laboratories and Its Products Forest Laboratories'
growing line of products includes: Lexapro(R) (escitalopram
oxalate), an SSRI antidepressant indicated for the initial and
maintenance treatment of major depressive disorder and for
generalized anxiety disorder in adults; Namenda(R) (memantine HCl),
an N-methyl-D-aspartate (NMDA)-receptor antagonist indicated for
the treatment of moderate to severe Alzheimer's disease; Celexa(R)
(citalopram HBr), an antidepressant for adults; Benicar(R)*
(olmesartan medoxomil), an angiotensin receptor blocker indicated
for the treatment of hypertension; Benicar HCT(R) (olmesartan
medoxomil/hydrochlorothiazide), an angiotensin receptor blocker and
diuretic combination product indicated for the second-line
treatment of hypertension; Campral(R)* (acamprosate calcium), a
glutamate receptor modulator, indicated for the maintenance of
abstinence from alcohol in patients with alcohol dependence who are
abstinent at treatment initiation in combination with psychosocial
support; Combunox(TM) (Oxycodone HCl and Ibuprofen) an opioid and
NSAID combination indicated for the short-term management of acute,
moderate to severe pain expected to be available in the U.S. in
early 2005. About PAION PAION, a biopharmaceutical company based in
Aachen, Germany, aims to become a leading provider of innovative
drugs for the treatment of stroke and other thrombotic diseases. In
addition to Desmoteplase, the company is developing the
neuroprotective drug Enecadin for stroke, and the anti- thrombotic
Solulin. With a core competence in advancing purchased or in-
licensed drug candidates through the clinical development and
regulatory approval process, PAION believes it is well-equipped to
achieve this goal. The company today employs approximately 60
people and has raised 51 million euro in four financing rounds
since its founding in 2000. More information is available at
http://www.paion.de/. Except for the historical information
contained herein, this release contains "forward-looking
statements" within the meaning of the Private Securities Reform Act
of 1995. These statements are subject to risks and uncertainties
that affect our business, including risk factors listed from time
to time in the Company's SEC reports, including the Company's
Annual Report on Form 10-K for the fiscal year ended March 31,
2004, and on form 10-Q for the periods ended June 30, 2004, and
September 30, 2004. Actual results may differ materially from those
projected. *Benicar(R) is a registered trademark of Sankyo Pharma,
Inc., Campral(R) is a registered trademark under license from Merck
Sante s.a.s., subsidiary of Merck KGaA, Darmstadt, Germany.
Activase(R) is a registered trademark of Genentech, Inc.
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGODATASOURCE:
Forest Laboratories, Inc. CONTACT: Charles E. Triano, Vice
President, Investor Relations of Forest Laboratories,
+1-212-224-6714, Web site: http://www.frx.com/ http://www.paion.de/
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