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Athenagen Initiates Phase
II Clinical Trial in Alzheimer’s Disease
SOUTH SAN FRANCISCO
, CA – DECEMBER 13, 2006
Athenagen, Inc., a privately held
biopharmaceutical company focused in the area of neurovascular
diseases, announced today the commencement of a Phase II
clinical study of the company’s
lead compound, GTS-21, in patients with Alzheimer’s disease.
GTS-21, a novel, orally active alpha-7 nicotinic acetylcholine
(nACh) receptor agonist, was previously demonstrated to improve
cognition in a proof-of-concept study in patients with schizophrenia
and in healthy volunteers.
“In preclinical and clinical studies, GTS-21 has shown
positive benefits in the ability to improve attention, learning
and memory impairment, all of which are debilitating cognitive
deficiencies associated with numerous medical conditions,” said
W. Scott Harkonen, MD, Athenagen President and Chief Executive
Officer. “We are excited to advance GTS-21 in Alzheimer’s
disease as part of our broader strategy to establish efficacy
of this product in multiple cognitive deficiencies; initially
Alzheimer’s disease, ADHD and schizophrenia.”
The current Phase II clinical trial
is a placebo-controlled, double-blind, randomized dose-ranging
study designed to evaluate both safety and cognitive effects
in patients with early Alzheimer’s
disease. More than 4.5 million older Americans have Alzheimer’s
disease, a condition of aging that affects both memory and
learning abilities. The 60-patient study is being conducted
by Sheldon H. Preskorn, MD, Professor and Chair for the Department
of Psychiatry and Behavioral Sciences at the University of
Kansas School of Medicine, Wichita. Athenagen expects to complete
this trial in the second quarter of 2007.
Initial results from a proof-of-concept study in patients
with schizophrenia were published in the June issue of the
Archives of General Psychiatry (2006; 63:630-638), a peer-reviewed
publication of the American Medical Association. The NIH-funded
study was conducted by Dr. Robert Freedman, Professor and Chairman
of the Department of Psychiatry at the University of Colorado
Health Sciences Center.
About GTS-21 GTS-21 (also known as DMBX-A), is a novel, small-molecule,
orally active and selective alpha-7 nicotinic acetylcholine
(nACh) receptor agonist that has demonstrated memory and cognition
enhancement activity in human clinical trials. GTS-21 has been
studied in multiple Phase I studies in healthy volunteers and
one Phase I/II study in schizophrenic patients. In all studies,
the compound was well tolerated. In a Phase I multi-dose, double-blind,
placebo controlled study in healthy adults, GTS-21 also demonstrated
cognitive enhancement across all doses, with a statistically
significant improvement in attention- and memory-related tasks
(Kitagawa, et al. Neuropsychopharmacology (2003), 28, 542-551).
About Athenagen
Athenagen, Inc., located in South San Francisco, is engaged
in the discovery and development of small-molecule drugs
to treat neurovascular disease indications, such as Alzheimer’s
disease, AMD and cognitive disorders. The company has two
fundamental technology platforms: (i) beta-secretase inhibitors
for the treatment of Alzheimer’s disease; and (ii)
nACh receptor agonists and antagonists for the treatment
of angiogenesis mediated diseases and cognitive disorders.
Athenagen currently has four product development programs
based on these two technologies: ATG003, a topical (eye drop)
anti-angiogenesis compound for neovascular AMD in a Phase
I study; GTS-21, an oral agonist of the alpha-7 nACh receptor
pathway for cognition enhancement currently in a Phase II
study; ATG002, a topical (gel) pro-angiogenesis compound
for diabetic foot ulcers currently in a Phase I/II study;
and multiple clinical candidates from the beta-secretase
inhibitor program approaching Phase I/II study for Alzheimer’s
disease in 2007.
For more information: www.athenagen.com.
CONTACT:
W. Scott Harkonen, M.D.
President and CEO
(650) 869-7600
press@athenagen.com
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