Patient Recruitment to Resume Without Modification of Protocol for Desmoteplase Phase IIB/III Stroke Study DIAS-2
October 28 2006 - 12:08AM
PR Newswire (US)
NEW YORK, Oct. 27 /PRNewswire-FirstCall/ -- Forest Laboratories,
Inc. (NYSE:FRX) and its development partner for desmoteplase, PAION
AG (Aachen, Germany), today announced that the independent Data
Monitoring Committee (DMC) for the DIAS-2 Phase IIB/III study met
and informed the Steering Committee and the Companies that it has
reviewed the cumulative data from the study provided by the
Companies and recommended the resumption of patient enrollment into
DIAS-2 with no modification of the protocol. At this meeting, the
DMC reviewed data from 170 randomized subjects. The DIAS-2 study is
evaluating PAION's drug candidate desmoteplase in patients with
acute ischemic stroke. The Companies continue to expect that
enrolment will be completed by the end of 2006 and that study
results will be available by the middle of 2007. (Logo:
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO ) About
Desmoteplase Desmoteplase, the most specific plasminogen activator
known today, is a genetically engineered version of a
clot-dissolving protein found in the saliva of the vampire bat
Desmodus rotundus. Currently in Phase III, Desmoteplase has been
successfully tested in two independent Phase II studies for the
treatment of acute ischemic stroke between 3 and 9 hours after
onset of symptoms and has received fast-track designation from the
U.S. Food and Drug Administration. About Forest Laboratories and
Its Products Forest Laboratories (http://www.frx.com/ ) is a
US-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 for 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 Sankyo Pharma, 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 Reform Act of 1995. These
statements involve a number of risks and uncertainties, including
the difficulty of predicting FDA approvals, 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 Company's SEC
reports, including the Annual Report on Form 10-K for the fiscal
year ended March 31, 2006 and on Form 10-Q for the period ended
June 30, 2006.
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO
http://photoarchive.ap.org/ DATASOURCE: Forest Laboratories, Inc.
CONTACT: Charles E. Triano, VP, Investor Relations, of Forest
Laboratories, Inc., +1-212 224-6714, or Web site:
http://www.frx.com/
Copyright
Forest Road Acquisition (NYSE:FRX)
Historical Stock Chart
From Jun 2024 to Jul 2024
Forest Road Acquisition (NYSE:FRX)
Historical Stock Chart
From Jul 2023 to Jul 2024