Applied NeuroSolutions’ Q3 2008 Alzheimer’s Disease Serum Diagnostic Development Program Update
Vernon Hills, IL November 19, 2008 - Applied NeuroSolutions, Inc. (OTC BB:APNS, www.AppliedNeuroSolutions.com), a Company focused on the development of an integrated product portfolio for the treatment and diagnosis of Alzheimer’s disease (“AD”), recently announced its financial results for the quarter ended September 30, 2008 and today provides an update on its serum diagnostic development program.
In order to advance the development of APNS’s serum-based diagnostic programs for AD, the Company created new, proprietary tau-based tools and identified companies with specialized technologies in the first half of 2008. In Q3 2008, APNS established key working arrangements with specialized technology companies to achieve APNS’s next milestone, which is to establish the feasibility of its serum-based diagnostic test. APNS believes it could begin generating revenue from its serum diagnostic program in late-2009 to mid-2010 under the Clinical Laboratory Improvement Amendment of 1988 (“CLIA”), if the Company is successful in achieving this next milestone. CLIA-certified companies can supply either “investigational use only” or “research use only” tests, which do not require FDA approval, but are subject to certain regulatory conditions.
There is a significant unmet need for an easy-to-administer, reliable and cost-effective AD diagnostic test. Patients with a neurodegenerative disease such as AD are likely to benefit most from early diagnosis and treatment. It is currently estimated that over 30 million people worldwide have AD and that number could grow to 106 million by 2050. A serum-based AD test that achieves strong acceptance in the medical and research community yields estimates for the global market that could reach $1 billion.
Commenting on the Company’s diagnostic program, Ellen R. Hoffing, APNS’s Chairman, President and Chief Executive Officer, stated, “I am pleased with our progress toward developing a serum-based diagnostic for AD. We continue to build from our extensive knowledge of our P-Tau 231 biomarker, which is directly linked to neurofibrillary tangles, one of the two hallmark pathologies of AD. We are excited that our efforts are directed toward a truly ground-breaking, patient-friendly, diagnostic test that could have a significant impact on the way physicians “rule in” or “rule out” AD, as well as how researchers use biomarkers in clinical trials to develop new AD therapeutic solutions.”
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.
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 its 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 neurological 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 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 www.AppliedNeuroSolutions.com, and review the company's filings with the Securities and Exchange Commission.
Contact:
Applied NeuroSolutions 847-573-8000
Ellen Hoffing, President, CEO
David Ellison, CFO |