Presentations at 2009 Alzheimer’s Association International
Conference on Alzheimer’s Disease Support Ongoing Phase 2 Trial
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.
