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Applied NeuroSolutions, Inc. (APSN.OB) is a development stage biotechnology company focused on the development of products for the early diagnosis and treatment of Alzheimer's disease (AD).

Alzheimer’s Disease
Alzheimer’s disease is the most common cause of dementia among people age 65 and older.  Dementia is the loss of memory, reason, judgment and language to such an extent that it interferes with a person’s daily life and activities.  Currently it is estimated that over five million people in the U.S., and almost 35 million worldwide, have Alzheimer’s disease and the national cost of caring for people with Alzheimer’s is estimated to exceed $148 billion annually.  By 2050, it is estimated that 16 million people in the U.S. will have Alzheimer’s, and the global prevalence of Alzheimer’s is expected to be greater than 115 million.

Science & Technology
Our core technology in the AD field is based on exclusive licenses with Albert Einstein College of Medicine (AECOM) covering all diagnostic and therapeutic applications in the field of neurodegenerative disease discovered in the AECOM laboratories of Peter Davies, Ph.D.  Dr. Davies, the Company’s founding scientist, is the Burton P. and Judith Resnick Professor of Alzheimer’s Disease Research at AECOM, and was the recipient of the Lifetime Achievement Award in Alzheimer’s Disease at the Alzheimer’s Association’s 11th International Conference on Alzheimer’s Disease (ICAD) held in Chicago in July 2008.

Diagnostic Program
Currently there are no approved diagnostic tests to detect AD and follow its progression.  Confirmation of diagnosis is performed through a series of behavioral measurements and brain scans.  Definitive diagnosis can be made only from examination of postmortem brain tissue samples.  Applied NeuroSolutions’ tests would provide a significant breakthrough in supporting definitive early diagnosis.

Our diagnostic program is based on Dr. Davies’ research of the tau pathology, and revolves around developing a pipeline of tau-based diagnostic tests that would detect AD at a very early stage.  Our product farthest along in development is a CSF-based diagnostic test to detect whether a person has AD.  This diagnostic, based upon the detection of a certain AD associated protein found in the CSF of AD patients (P-Tau 231), has demonstrated, based on published research validation studies, an overall sensitivity and specificity in the range of 85% to 95% (depending on patient diagnosis).  This test is based on extensive testing in our lab, utilizing in excess of 2,500 CSF samples to differentiate patients diagnosed with AD from patients diagnosed with other forms of dementia and relevant neurological diseases, including major depression, as well as age-matched healthy controls.

We are utilizing the knowledge gained during the development of our CSF-based diagnostic test to develop serum-based tests to detect Alzheimer’s disease.  Our focus is on advancing the development of a blood-based test for AD to commercialization, by selling through reference labs under the Clinical Laboratory Improvement Amendment of 1988 (CLIA), and to pharma and biotech companies for use in their drug development efforts and clinical trial screening.

Therapeutic Program – Collaboration with Eli Lilly and Company

Alzheimer’s disease drug discovery and development activities are focused on novel targets, including one targeting a common intracellular phosphorylation pathway with the potential to impact both hallmark disease pathologies, amyloid plaques and neurofibrillary tangles.  In November 2006, we entered into an agreement with Eli Lilly and Company to develop therapeutics to treat AD.  The agreement forms a collaboration that combines the expertise, research tools and tau-based approach advanced by Dr. Davies and our team at Applied NeuroSolutions, with the scientists, therapeutic development expertise and financial resources at Eli Lilly and Company.  The agreement calls for Lilly to receive the exclusive worldwide rights to the intellectual property related to our expertise in understanding the molecular neuropathology of AD as it pertains to the formation of neurofibrillary tangles.  Lilly will fund the vast majority of all pre-clinical research and development and will fully finance the clinical testing, manufacturing, sales and marketing of AD therapeutics developed from our collaboration.

Research Products
We market a transgenic mouse containing the human tau gene that develops human paired helical filaments, the building blocks of the neurofibrillary tangles, which are known to be involved in the pathology of Alzheimer’s disease. The pathology in these mice is Alzheimer-like, with hyperphosphorylated tau accumulating in cell bodies and dendrites as neurofibrillary tangles.  In addition, these transgenic mice have exhibited extensive neuronal death that accompanies the tau pathology.  These transgenic mice could be used for testing the efficacy of therapeutic compounds.  To date, no widely accepted animal model that exhibits both AD pathologies has been developed.  The mice are currently available through Jackson Laboratories.

Corporate History
Applied NeuroSolutions, Inc. was created from the merger of Molecular Geriatrics Corporation with Hemoxymed, Inc. on September 10, 2002.  We changed our name to Applied NeuroSolutions, Inc. in October 2003 to reflect our focus upon the diagnosis and treatment of AD.  Our core science and technology is derived from Molecular Geriatrics Corporation, founded in 1992 based on the work of Peter Davies, Ph.D. at Albert Einstein College of Medicine.