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JDRF Partners with CoMentis for Diabetic Macular Edema Clinical Trial.


NEW YORK & SOUTH SAN FRANCISCO, Calif. -- 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 please visit 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 diseases such as 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.

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. The company has raised more than $57 million in venture financing. Key investors include Sanderling Ventures, Clarus Ventures, Index Ventures, Charter Life Sciences and Astellas Venture Capital. For more information: www.comentis.com.
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Publication:Business Wire
Date:Sep 20, 2007
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