Healthcare Industry News:  Alzheimer's 

Biopharmaceuticals Neurology

 News Release - June 18, 2007

CoMentis Receives FDA Clearance to Begin Human Clinical Trials for Its Disease-Modifying Alzheimer's Therapy

Highly Potent Beta-Secretase Inhibitor to Enter the Clinic

SOUTH SAN FRANCISCO, CA--(Healthcare Sales & Marketing Network)--Jun 18, 2007 -- CoMentis, Inc., a privately held biopharmaceutical company, announced today it is initiating a Phase I first-in-man study of its proprietary, orally bioavailable, small-molecule beta-secretase inhibitor CTS-21166, which is being developed as a disease-modifying treatment for Alzheimer's disease (AD). In preclinical studies, CTS-21166 exhibits excellent efficacy, selectivity, brain penetration and pharmacologic activity.

"This is a significant achievement for CoMentis and for Alzheimer's disease drug development," stated W. Scott Harkonen, M.D., President and Chief Executive Officer. "CTS-21166 is an entirely new approach to the treatment of AD because it is a disease-modifying agent targeting beta-secretase, a critical enzyme involved in the pathogenesis of Alzheimer's disease, and it has the potential to become the first-in-class therapeutic agent."

The CoMentis initial Phase I trial in healthy volunteers is designed as a dose escalation study to measure the safety, tolerability and pharmacokinetics of CTS-21166 following intravenous administration. Forty-eight subjects will receive one of several different doses or placebo. The company expects to begin generating human clinical data by the end of 2007 and to begin Phase II studies in Alzheimer's patients in 2008.

Beta-Secretase and Alzheimer's Disease

Drs. Jordan Tang and Arun Ghosh, two of the scientific founders of CoMentis, are pioneers in the field of aspartic proteases. Since publication of the first beta-secretase inhibitor in 2000, Dr. Tang has led the characterization of this enzyme's role in Alzheimer's disease and Dr. Ghosh has led the construct of drug candidates to inhibit its activity. The action of this enzyme on the amyloid precursor protein leads to the formation of plaques in the brain and is implicated in the development of Alzheimer's disease. Inhibition of beta-secretase reduces beta amyloid production and could slow the progression of Alzheimer's disease. CTS-21166 is the first of several highly selective and potent beta-secretase inhibitors being developed by CoMentis that are highly active in preclinical models of Alzheimer's disease.

"This is the most exciting target today for intervention in the pathogenesis of Alzheimer's disease," said Dr. Tang, who holds the J.G. Puterbaugh Chair in Medical Research at the Oklahoma Medical Research Foundation. "Beta-secretase is involved at a very early stage in the disease, and if we could block the activity of this enzyme, we could prevent many of the harmful steps that follow and drastically reduce the impact of Alzheimer's disease."

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.

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. In 2000, 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.

CoMentis currently has four 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; GTS-21, an oral agonist of the alpha-7 nACh receptor pathway for cognition enhancement; and ATG-2, a topical (gel) containing a pro-angiogenesis compound for diabetic foot ulcers. 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.


Source: CoMentis

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