JDRF Partners with CoMentis for Diabetic Macular Edema Clinical Trial
New York, NY and South San Francisco, CA - September 20, 2007
The Juvenile Diabetes Research Foundation, the world's largest charitable funder of type 1 diabetes research, today announced a partnership with CoMentis, Inc. to support the biotechnology company's human clinical trial of ATG3, a topical eye drop therapy for diabetic macular edema.
"This partnership provides a unique opportunity to accelerate the clinical trials of a compound that has shown promise in addressing diabetic macular edema, a serious complication of diabetes that can lead to vision loss," said Barbara Araneo, Complications Therapeutic Program Director at JDRF. "If successful, CoMentis's novel approach to diabetic macular edema has the potential to reduce the severity of the complication and improve the vision of people with diabetes."
"We are pleased to be working with JDRF to extend the application of our anti-angiogenesis eye drop therapy beyond age-related macular degeneration to address the huge problem of diabetic macular edema," stated W. Scott Harkonen, M.D., President and Chief Executive Officer of CoMentis, Inc.
The Phase IIa trial, designed to evaluate
the safety and activity of ATG-3 in improving vision in patients
with diabetic macular edema, is planned to begin in the third
quarter of 2007, with results expected in about nine months.
This study is being lead by Dr. Peter Campochiaro, Professor
of Ophthalmology at the Wilmer Eye Institute, Johns Hopkins
University. A larger, Phase IIb study in patients with type
1 and type 2 diabetes will follow later in 2008.
ATG3, a proprietary formulation, of mecamylamine
that is also in development for the treatment of age-related
macular degeneration (AMD), is an antagonist of the nicotinic
acetylcholine receptor pathway that may counter balance the
vascular leak and angiogenesis of DME.
ATG3 was initially developed as a topical
eye drop for AMD. In a Phase I study in healthy volunteers,
ATG3 was found to be safe and well tolerated with very little
to no systemic exposure. It is currently being studied in an
ongoing, large, multi-center international Phase II study in
patients with neovascular (or wet) AMD. Inhibition of the cholinergic
angiogenesis pathway, which was discovered and characterized
at Stanford by two of CoMentis's founding scientists, also down regulates vascular endothelial-derived growth factor (VEGF) dependent vascular leak and angiogenesis. Studies in animal models have demonstrated that the eye drop application penetrates well into the retina and choroid, and reduces new blood vessel growth in the eye.
About Diabetic Macular Edema
Approximately 10% of the 21 million people in the US who have
type 1 or type 2 diabetes suffer from diabetic macular edema,
a condition that causes swelling of the retina due to leaking
of fluid from blood vessels within the macula. When fluid leaks
into the center of the macula, the part of the eye where sharp,
straight-ahead vision occurs, it causes blurred vision. Visual
loss from edema can progress over a period of months and make
it impossible to focus.
About JDRF
JDRF was founded in 1970 by the parents of children with type
1 diabetes - a disease that strikes children, adolescents,
and adults suddenly, makes them insulin dependent for life,
and carries the constant threat of devastating complications.
Since inception, JDRF has provided more than $1.16 billion
to diabetes research worldwide. More than 85 percent of JDRF's
expenditures directly support research and research-related
education. JDRF's mission is constant: to find a cure for diabetes
and its complications through the support of research.
For more information: www.jdrf.org
About CoMentis
CoMentis, Inc. has its headquarters in South San Francisco, with research operations in both South San Francisco and Oklahoma City. The company is engaged in the discovery and development of small-molecule drugs to treat Alzheimer's disease, age-related macular degeneration (AMD) and cognitive disorders. The company has two fundamental technology platforms: (i) aspartic protease inhibitors, including beta-secretase inhibitors for Alzheimer's disease; and (ii) nicotinic acetylcholine receptor (nAChR) agonists and antagonists for the treatment of angiogenesis mediated diseases and cognitive disorders.
Originally founded in 2004 as Athenagen,
Inc., the company was re-named CoMentis following the August
2006 merger with Zapaq, Inc., which created a leading neurovascular
disease franchise. Zapaq was founded in 2001 by Jordan Tang,
Ph.D., of the Oklahoma Medical Research Foundation, and Arun
Ghosh, Ph.D., now at Purdue University, both experts in the
field of aspartic proteases. Dr. Tang's groundbreaking discovery
of beta-secretase, an aspartic protease which is a critical
enzyme in beta amyloid production, was published in Proceedings
of the National Academy of Sciences in 2000.
CoMentis currently has three product development
programs based on its two technologies: ATG-3, a topical (eye
drop) anti-angiogenesis compound for neovascular AMD; CTS-21166,
an orally active beta-secretase inhibitor for Alzheimer's disease; and GTS-21, an oral agonist of the alpha-7 nACh receptor pathway for cognition enhancement.
For more information: www.comentis.com.
CONTACT COMENTIS:
W. Scott Harkonen
M.D,President & CEO
Office (650) 869-7600
press@comentis.com
CONTACT JUVENILE
DIABETES RESEARCH FOUNDATIONS:
WPeter Cleary
National Director of Media Relations
Office (212) 479-7553
pcleary@jdrf.org
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