Patient Recruitment for Desmoteplase Phase IIB/III Stroke Study DIAS-2 Placed on Hold
October 25 2006 - 9:52AM
PR Newswire (US)
NEW YORK, Oct. 25 /PRNewswire-FirstCall/ -- Forest Laboratories,
Inc. (NYSE:FRX) and its development partner for desmoteplase, PAION
AG (Aachen, Germany), today announced that the Steering Committee
of the Phase IIB/III stroke study, DIAS-2, has decided in agreement
with the Companies to place patient recruitment temporarily on hold
until further data have been analyzed. The DIAS-2 study is
evaluating PAION's drug candidate desmoteplase in patients with
acute ischemic stroke. (Logo:
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO ) The
Steering Committee followed a recommendation by the independent
Data Monitoring Committee (DMC). The DMC had requested additional
data in order to facilitate the evaluation of a potential safety
signal, which was not specified further by the DMC. The DMC had
notified the Steering Committee in its statement that no conclusion
on the safety or efficacy of desmoteplase should be drawn based
upon this recommendation. The requested data has been processed and
will be provided to the DMC within the next day. 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 ischaemic
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
Forest Laboratories, Inc.'s 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. and Replidyne, Inc.'s Prospectus on Form S-1
and on Form 10-Q for the period ended June 30, 2006.
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGODATASOURCE:
Forest Laboratories, Inc. CONTACT: Charles E. Triano, VP - Investor
Relations of Forest Laboratories, Inc., +1-212-224-6714, Web site:
http://www.frx.com/
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