Applied NeuroSolutions To Offer P-Tau 231 Test For Use In Alzheimer's Disease Clinical Trials

Main Category: Alzheimer's / Dementia
Article Date: 16 May 2008 - 2:00 PST

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Applied NeuroSolutions, Inc. (OTC BB:APNS)( http://www.AppliedNeuroSolutions.com), a company focused on the development of products for the early diagnosis and treatment of Alzheimer's disease ("AD"), today announced an initiative to provide its P-Tau 231 cerebrospinal fluid (CSF) test to companies undertaking AD clinical trials. Potential customers, which include pharmaceutical, biotechnology and imaging companies, may use the P-Tau 231 test to aid in screening patients for clinical trials and to track P-Tau 231 levels pre- and post-drug treatment. Applied NeuroSolutions has identified over 50 companies with 100 plus compounds in active clinical development for AD. Revenue generated from providing this service would help support the further development of Applied NeuroSolutions's diagnostic pipeline, with a goal of delivering a serum-based test for the early diagnosis of AD.

The Company's P-Tau 231 test has been extensively researched and has overall sensitivity and specificity of 85% to 95%. This is based on a broad range of testing by US and international academic researchers to differentiate patients diagnosed with AD from patients diagnosed with other forms of dementia and other relevant neurological diseases, including major depression, as well as age-matched healthy controls. The data generated from over 2,000 CSF samples have been published in 21 peer-reviewed articles in leading neurology and other scientific journals.

In addition, Applied NeuroSolutions, has to date used the P-Tau 231 test to analyze over 1,500 samples for leading global pharmaceutical companies and is now offering this service to additional customers in response to the growing number of clinical trials to develop better solutions for the increasing AD population. Given the substantial investment required to conduct clinical trials, collection of information provided by the P-Tau 231 test can offer a cost- effective tool to optimize companies' AD drug development programs.

According to Dr. Mony de Leon, Professor of Psychiatry and Director Center for Brain Health at NYU School of Medicine "P-Tau 231 is now a validated biomarker of neurofibrillary-tangles, a hallmark pathology of Alzheimer's disease. Among all of the potential AD biomarkers, P-Tau 231 has consistently been the most successful in the diagnosis of AD, not only in the differential diagnosis of Alzheimer's disease in contrast to other dementias, but also in the very important early stages before the clinical manifestation of AD where the opportunity for therapeutic impact is greatest."

About Applied NeuroSolutions

Applied NeuroSolutions, Inc. (OTC BB:APNS)(News) is developing diagnostics and therapeutics to detect and treat Alzheimer's disease (AD) building on discoveries originating from the Albert Einstein College of Medicine. Applied NeuroSolutions is in a collaboration with Eli Lilly and Company to develop novel therapeutic compounds to treat the progression of AD. For the diagnostic pipeline, Applied NeuroSolutions is focused on both cerebrospinal fluid (CSF) and serum tests to detect AD at a very early stage. The P-Tau 231 test now being offered for use in clinical trials can effectively differentiate AD patients from those with other diseases that have similar symptoms. There is currently no FDA approved diagnostic test to detect AD. Alzheimer's disease currently afflicts over five million Americans, and the world market for AD therapy is currently estimated to be 30 million patients. For more information, visit http://www.AppliedNeuroSolutions.com

This press release contains forward-looking statements about Applied NeuroSolutions. The company wishes to caution the readers of this press release that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, the risks associated with new product development and commercialization, clinical trials, intellectual property, regulatory approvals, potential competitive offerings, and access to capital. For further information, please visit the company's website at http://www.AppliedNeuroSolutions.com, and review the company's filings with the Securities and Exchange Commission.

http://www.AppliedNeuroSolutions.com