Elan and Transition Therapeutics Announce Phase 1 Data Showing ELND005 Achieves Desired Concentrations in Brain Tissue and Cerebrospinal Fluid

Mon Jul 13, 2009 6:30am EDT
 
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Presentations at 2009 Alzheimer`s Association International Conference on
Alzheimer`s Disease Support Ongoing Phase 2 Trial
DUBLIN & TORONTO & VIENNA--(Business Wire)--
Elan Corporation, plc (NYSE: ELN) and Transition Therapeutics Inc. (TSX: TTH,
NASDAQ: TTHI) today presented Phase 1 data demonstrating that treatment with
ELND005 (scyllo-inositol formerly known as AZD-103), achieves desired
concentrations in human brain tissue and cerebrospinal fluid when given orally.
Preclinical data also were presented showing that ELND005 administration is
associated with preservation of choline acetyltransferase (ChAT), reflecting
preservation of nerve cells that are critical to memory function in the brain.
ELND005 is an orally-administered drug candidate in Phase 2 trials for the
treatment of mild to moderate Alzheimer`s disease. These results were presented
at the 2009 Alzheimer`s Association International Conference on Alzheimer`s
Disease (ICAD 2009) in Vienna, Austria. 

In a poster entitled, "Oral Amyloid Anti-aggregating Agent ELND005 is Measurable
in CSF and Brain of Healthy Adult Men," the researchers describe results of a
Phase 1 study in which eight healthy adults each received 2,000 mg of ELND005
twice a day for 10 days. Concentrations of ELND005 in cerebrospinal fluid were
measured directly, while brain tissue concentrations were measured
non-invasively using a novel magnetic resonance spectroscopy technique and were
determined to be within the range associated with efficacy in previous animal
studies that employed a transgenic animal model of Alzheimer`s Disease. ELND005
was well tolerated by these study participants with no severe, serious, or
treatment-limiting adverse events observed. 

"Achieving a clinically beneficial concentration of drug in brain tissue and
cerebrospinal fluid has presented a significant hurdle to other drugs
investigated to treat Alzheimer`s Disease, so this is an important proof of
concept for us," said Elan president Carlos V. Paya, MD, PhD. "We look forward
to completing and reporting results from our ongoing Phase 2 study of ELND005 in
patients with mild to moderate Alzheimer's disease, which completed enrollment
in October 2008." 

In a second poster, entitled "Quantification of Cholinergic Degradation and
Adult Neurogenesis in TgCRND8 Mice Following Treatment with Scyllo-Inositol
(ELND005)," Dr. JoAnne McLaurin and colleagues from the University of Toronto
analyzed levels of the enzyme Choline Acetyltransferase (ChAT) in an animal
model of Alzheimer`s disease. As in humans, these Alzheimer`s animal models
exhibit damage to nerve cells in a region of the brain called the "basal
forebrain" that use the neurotransmitter acetylcholine to transmit nerve
impulses critical to memory functions to other nerve cells in a brain region
important for memory function called the hippocampus. Animals treated with
ELND005 exhibited significantly more ChAT levels compared to untreated animals. 

"There is evidence that amyloid plaque formation drives the decline in memory
and cognition associated with Alzheimer`s disease," said JoAnne McLaurin, PhD,
professor at the University of Toronto`s Centre for Research in
Neurodegenerative Diseases. "Although more research is necessary, the findings
presented today suggest that ELND005 may have the ability to prevent the loss of
ChAT that results from damage to cholinergic neurons in the brain, thereby
potentially protecting against cognitive decline in individuals with Alzheimer`s
disease." 

"We have conducted a robust preclinical and Phase 1 research program of ELND005
that has demonstrated that the drug is able to cross the blood-brain barrier,
which should allow it to target the disaggregation of amyloid beta in the
brain," said Dr. Tony Cruz, chairman and chief executive officer of Transition. 

In 2006, Elan and Transition entered into an exclusive, worldwide collaboration
agreement for the joint development and commercialization of ELND005 for the
treatment of Alzheimer`s disease and other indications. 

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 can facilitate
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. 

ELND005 is currently in a Phase 2 clinical study, which completed enrollment in
October 2008. 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. The planned treatment period for each patient
is approximately 18 months. 

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. 

About Transition

Transition is a biopharmaceutical company, developing novel therapeutics for
disease indications with large markets. Transition's lead products include
ELND005 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 and 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 scyllo-inositol (ELND005) 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 ELND005 are not predictive of results to be obtained in
Phase 2 or later clinical trials, the patent issued with respect to ELND005 may
not 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. 



Elan:
MEDIA:
Miriam Mason, 650-278-7113
Miriam.Mason@elan.com
or
Mary Stutts, 650-794-4403
Mary.Stutts@elan.com
or
INVESTORS:
Chris Burns, 800-252-3526
Chris.Burns@elan.com
or
David Marshall, 353-1-709-4444
David.Marshall@elan.com
or
Transition Therapeutics:
Dr. Tony Cruz
Chief Executive Officer
416-260-7770, x.223
tcruz@transitiontherapeutics.com
or
Elie Farah
President & Chief Financial Officer
416-260-7770, x.203
efarah@transitiontherapeutics.com



Copyright Business Wire 2009

 

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