Athenagen Initiates Clinical
Development
of its Anti-angiogenic Eye Drop Therapy for AMD
SOUTH SAN FRANCISCO
, CA – AUGUST 21, 2006
Athenagen, Inc., a privately held biopharmaceutical
company, said today that it has begun testing ATG003, its topical
(eye drop) therapy for age-related macular degeneration (AMD),
in a Phase I clinical trial. ATG003 is a proprietary topical
formulation of mecamylamine that has shown efficacy in animal
models and is a possible alternative to current therapies for
AMD which require frequent needle injections directly in the
eye. This study represents the first human study of an eye
drop anti-angiogenic therapy for AMD, with a Phase 2 efficacy
study expected to follow early next year.
AMD is characterized by abnormal blood vessel
growth in the eye, resulting in significant loss of vision.
ATG003 is a novel anti-angiogenic agent that inhibits endothelial
nicotinic acetylcholine (nACh) receptors and has been shown
to decrease angiogenesis (new blood vessel growth) as well
as vascular permeability, two well-known hallmarks of neovascular
AMD. Athenagen’s study is a randomized, placebo-controlled,
ascending dose clinical trial designed to evaluate ocular tolerability
and safety for up to 14 days.
“Complementing our promising pre-clinical
efficacy studies are robust data demonstrating excellent penetration
of the drug to the back of the eye,” stated M. (Ken)
Kengatharan, Ph.D., co-founder and VP of Pre-clinical R&D
at Athenagen. “Developed by our scientists, this proprietary
eye drop formulation of mecamylamine enables delivery of drug
to the retina and choroid with very little reaching the systemic
blood circulation. The formulation has been well tolerated
in preclinical safety modelsat all doses to be used in human
testing.”
There are approximately two million AMD
patients in the United States, and this disease is the number
one cause of vision loss and legal blindness in adults over
60 in the U.S. There is no cure for AMD and the standard-of-care
is highly invasive, requiring needle injections directly in
the eye every 4 to 6 weeks.
“Given the prevalence of AMD and the
invasive nature of current treatments, a topical non-invasive
eye drop for treating this disease would be a welcome addition
to our clinical arsenal,” stated Michael Marmor, M.D.,
Professor of Ophthalmology, Stanford University School of Medicine.
“This is a significant advancement
in the development of new medicines for AMD,” commented
W. Scott Harkonen, M.D., President and Chief Executive Officer. “We
expect to generate data from our Phase I study by the end of
the year and plan to move directly into a larger safety and
efficacy study in the first part of 2007.”
About AMD
AMD occurs when abnormal blood vessels behind the retina
start to grow under the macula, the light-sensitive tissue
at the back of the eye. These new blood vessels tend to be
very fragile and often leak blood and fluid. The blood and
fluid raise the macula from its normal place at the back of
the eye and lead to loss of central vision, often quite rapidly.
Although it rarely causes total blindness, AMD robs those affected
of their sharp central vision and can dim contrast sensitivity
and color perception. It destroys the clear, "straight
ahead" central vision necessary for reading, driving,
identifying faces, watching television, doing fine detailed
work, safely navigating stairs and performing other daily tasks.
Peripheral vision may not be affected, and it is possible to
see "out of the corner of your eye." The impact of
developing AMD can be devastating to those who were independent
and active prior to the onset of this impairment. Their visual
world gradually diminishes into a vague blur, making ordinary
daily activities challenging. Currently two million patients
in the U.S. suffer from neovascular AMD and this number is
expected to grow with an
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 entering 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 fordiabetic foot ulcers currently underan active IND
and ready for Phase I/II study; and two clinical candidates
from the beta- secretase inhibitor program approaching Phase
I study for Alzheimer’s disease in the first quarter
of 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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