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This excerpt taken from the ELN 6-K filed Dec 21, 2007. Dublin,
Ireland and Toronto, Ontario
– December 21, 2007 – Elan Corporation, plc (NYSE: ELN) and Transition
Therapeutics Inc. (NASDAQ: TTHI, TSX: TTH) today announced that the first
patient has been dosed in a Phase 2 clinical study of ELND005 (AZD-103) in
patients with Alzheimer’s disease. The study is a randomized,
double-blind, placebo-controlled, dose-ranging, safety and efficacy study in
approximately 340 patients with mild to moderate Alzheimer’s
disease. Approximately 65 sites in North America are expected to
participate in the program.
The
study
will evaluate both cognitive and functional endpoints, and each patient’s
participation is planned to last approximately 18 months.
For
information on enrollment, patients or caregivers should contact clinical sites
participating in the study directly. Participating sites can be found
by calling +1 877-687-8839. As sites become active, their details
also can be found by visiting www.clinicaltrials.gov. 1
About
ELND005 (AZD-103)
ELND005
is an orally-administered therapeutic agent that has received fast track
designation from the U.S. Food and Drug Administration (FDA) for treatment
of
mild to moderate Alzheimer’s disease. Fast track designation
facilitates development and may expedite regulatory review of drugs that the
FDA
recognizes as potentially addressing an unmet medical need for serious or
life-threatening conditions.
In
multiple Phase 1 studies that evaluated the safety, tolerability and
pharmacokinetic profile of ELND005 in approximately 110 healthy volunteers,
ELND005 was safe and well-tolerated at all doses and dosing regimens
examined. No severe or serious adverse events were
observed. Preclinical data suggest that ELND005 may act through the
unique mechanism of preventing and reversing the fibrilization of beta-amyloid,
a toxic peptide that forms plaques that are a key pathological feature of
Alzheimer’s disease.
About
Alzheimer’s Disease
Alzheimer’s
disease, a leading cause of dementia, is a progressive brain disorder that
gradually destroys a person's memory and ability to learn, reason, make
judgments, communicate and carry out daily activities. Alzheimer’s
disease may result from the build-up of toxic beta-amyloid peptides in the
brain. As Alzheimer’s disease progresses, individuals may also
experience changes in personality and behavior, such as anxiety, suspiciousness
or agitation, as well as delusions or hallucinations. It is currently
estimated that more than 5 million Americans have Alzheimer’s disease and more
than 24 million people worldwide over the age of 60 have some form of dementia
(Source: Alzheimer’s Association and Alzheimer’s Disease
International).
About
Elan
Elan
Corporation, plc is a neuroscience-based biotechnology company committed to
making a difference in the lives of patients and their families by dedicating
itself to bringing innovations in science to fill significant unmet medical
needs that continue to exist around the world. Elan shares trade on the New
York, London and Dublin Stock Exchanges. For additional information about the
company, please visit http://www.elan.com. 2
About
Transition Therapeutics Inc.
Transition
is a biopharmaceutical company, developing novel therapeutics for disease
indications with large markets. Transition's lead products include ELND005/
AZD-103 for the treatment of Alzheimer's disease and TT-223 for the treatment
of
diabetes. Transition has an emerging pipeline of preclinical drug candidates
acquired externally or developed internally using its proprietary drug discovery
engine. Transition's shares are listed on the NASDAQ under the symbol "TTHI"
and
the Toronto Stock Exchange under the symbol "TTH". For additional information
about the Company, please visit www.transitiontherapeutics.com.
Safe
Harbor / Forward-Looking Statements
This
press release contains forward-looking statements regarding the development
of
ELND005 (AZD-103) under the collaboration agreement between Elan and
Transition. These statements are based on Elan’s and Transition’s
current beliefs and expectations. ELND005 may not be successfully
developed or commercialized under the collaboration
agreement. Factors which could cause actual results to differ
materially from Elan’s and Transition’s current expectations include the risks
that clinical development of ELND005 fails due to safety or efficacy issues,
the
results from Phase 1 clinical trials and preclinical testing of ELN-005 are
not
predictive of results to be obtained in Phase 2 or later clinical trials, that
any patents will issue with respect to ELND005 or that, even if issued, whether
any such patents would provide substantial protection or commercial benefit,
the
development and commercialization of competitive therapies, the collaboration
agreement is terminated early or Elan and Transition encounter other
unexpected delays or hurdles. Drug development and commercialization
involves a high degree of risk. For more detailed information on the risks
and
uncertainties associated with Elan and Transition’s drug development and other
activities, see the periodic and current reports that Elan has filed with the
Securities and Exchange Commission and that Transition has filed with the
Securities and Exchange Commission and the Ontario Securities
Commission. Elan and Transition assume no obligation to update any
forward-looking statements, whether as a result of new information, future
events or otherwise
#####
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