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Media Contact: Deanne Eagle
Applied NeuroSolutions Ready to Ship First Research Mouse to Exhibit Key Alzheimer's Pathology
Vernon Hills, IL, April 6, 2005 - Applied NeuroSolutions (OTC BB:APNS, www.appliedneurosolutions.com) said today it finalized an agreement with the Research Foundation for Mental Hygiene, Inc. to utilize for its own research and to bring to market the first research animals that develop a key pathology that is an essential characteristic of Alzheimer's disease.
These animals, which are called Htau transgenic mice, have a segment of human DNA inserted into their genes. As a result, the mice express certain pathologic characteristics that resemble Alzheimer's disease in humans.
The lack of a suitable animal model has made it particularly difficult and expensive to develop effective drugs to treat Alzheimer's disease (AD), which afflicts human beings exclusively. According to BioPortfolio, Ltd, the market for AD therapy is expected to grow to 21 million patients by 2010 in the seven major pharmaceutical markets (USA, France, Germany, Italy, Spain, U.K. and Japan). Despite limited clinical effectiveness, sales in the U.S. in 2005 are estimated to be in excess of $2 billion. The apparent limited efficacy of current AD therapeutics would seem to provide an opportunity for other promising compounds.
According to the Company's founding scientist, Dr. Peter Davies, who is the Burton P. and Judith Resnick Professor of Alzheimer's Disease Research at Albert Einstein, "The Htau mice gives us an important tool for creating a new agenda in AD drug development; an agenda that focuses on early events in the disease process."
"For too long," Dr. Davies said, "AD drug development efforts have focused on inhibiting two pathologies associated with the disease - amyloid plaques and neurofibrillary tangles." However, he said, "By the time these pathologies are in place it may be too late for drugs to have a decisive effect. Recent breakthroughs in our understanding of the disease give us the intellectual tools to move beyond these first generation drugs. Now the Htau mouse will make this important project far more cost effective."
Dr. Davies' perspective on AD causation and his agenda for Drug Development were featured by Alice Dembner of the Boston Globe on March 29 in an article reprinted by the International Herald Tribune on March 30.
Under terms of the agreement announced today, Applied NeuroSolutions gains a license to use the Htau mice for its own AD drug development program, and also to market the mice to other parties. The company would realize approximately 50 per cent of the revenues it receives from the sublicense of the mice to outside parties such as research organizations and pharmaceutical companies that are working in the area of AD therapeutics.
The principal developers of the Htau mouse are Dr. Peter Davies, Ph. D of Albert Einstein College of Medicine and Karen Duff, Ph. D of New York State Nathan S. Kline Research Institute.
Dr Davies said that "Currently, there are transgenic mice available that develop some of the pathology associated with Alzheimer's, but they do not exhibit significant neuronal death, which is the major consequence of this disease."
"Another difference between our Htau mice and earlier attempts from other researchers, is that our mice develop an Alzheimer's disease pathology called neurofibrillary tangles resulting from the insertion of normal human tau into the mouse's genes," Dr. Davies said. "Previously, scientists had attempted to develop transgenic mice with Alzheimer's disease pathology by inserting mutated tau."
Davies said "The Htau mice, however, have a distribution of pathology that is much closer to that in humans with AD, with tangles forming in regions such as the cerebral cortex and the hippocampus. In further studies, there is good evidence showing neuronal degeneration and death following the appearance of the neurofibrillary tangles in the Htau mice, and this is something we really need to see in an animal model for Alzheimer's disease."
In partnership with Albert Einstein College of Medicine, Applied NeuroSolutions is developing products to diagnose and treat Alzheimer's disease based on a novel theory of AD and its pathology. In addition to the Htau mouse, APNS has developed a cerebrospinal fluid (CSF) assay that has consistently identified AD with much greater than 80% sensitivity and specificity in more than 2900 patient samples. This is the level of sensitivity and specificity that has been determined by the Ronald and Nancy Reagan Research Institute of the Alzheimer's Association to be the "industry standard" for AD diagnostics. In addition, the company is developing a blood serum test that would be sensitive and specific enough to also meet this "industry standard", as well as a new class of therapeutics to treat AD. There are currently no FDA-approved diagnostics for Alzheimer's disease.
This press release contains forward-looking statements. Applied NeuroSolutions 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 www.appliedneurosolutions.com, and review the company's filings with the Securities and Exchange Commission.