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Potential Multi-Biomarker Test for Alzheimer’s

  November, 14 2003 8:39
your information resource in human molecular genetics
Fremont, CA, November 10, 2003 — Ciphergen Biosystems, Inc. (Nasdaq: CIPH) announced the discovery of a novel biomarker pattern for potential diagnostic use that correctly classified >96% of Alzheimer’s Disease (AD) and >94% normal individuals using a 4 peak pattern of markers. Results were presented today at the Society for Neuroscience 33rd Annual Meeting in New Orleans. Ciphergen’s Biomarker Discovery Center® scientists, working in collaboration with Professor Kaj Blennow of Sahlgren’s University Hospital in Sweden, analyzed cerebrospinal fluid (CSF) from probable Alzheimer’s patients and age-matched normal individuals using Ciphergen’s SELDI ProteinChip Biomarker System and patented Expression Difference Mapping™ methodology. Profiling of CSF samples on a variety of ProteinChip Arrays revealed 39 candidate biomarkers (P-value < 0.0001) that were differentially expressed in samples from Alzheimer’s patients versus age-matched normal control individuals. Ciphergen scientists then used its proprietary Biomarker Patterns® software to select a pattern of four biomarkers that correctly classified 29 out of 30 Alzheimer’s patient samples and 33 out of 35 age-matched normal individuals. Further studies analyzing over 200 additional samples are underway to validate these markers for their utility in diagnosing early stage Alzheimer’s disease as well as in differentiating AD from other dementias using the Ciphergen platform.

Alzheimer’s disease is the most common form of dementia worldwide, afflicting approximately 10 percent of people over the age of 65 and nearly half of those at age 85. The pathology of the disease is characterized by the accumulation of amyloid plaques and neurofibrillary tangles in the brains of patients. Today, there is no simple test that can be used for the reliable diagnosis of Alzheimer’s disease. Existing biochemical markers lack the sensitivity and specificity for routine clinical use, particularly for differentiation of Alzheimer’s disease from other dementias. Moreover, there is also a pressing need for biomarkers to support the development of new disease modifying drugs. Novel markers that can differentiate patient cohorts for enrollment in clinical trials, assess dose-response and monitor drug efficacy and disease progression have the potential to greatly reduce cost and time of bringing these new therapies to market.

"We are delighted to see that our SELDI ProteinChip technology has enabled the discovery of biomarkers, which potentially may be used to diagnose Alzheimer’s disease," stated William E. Rich, President and CEO of Ciphergen Biosystems. "We also believe that pharmaceutical companies developing Alzheimer’s therapeutics would greatly benefit from a protein-based test to help with compound selection and treatment monitoring."

Professor Kaj Blennow of the Sahlgren’s University Hospital commented: "The increasing awareness of the possibilities for drug treatment of AD has made people with memory disturbances seek medical advice very early. In this phase of the disease, there is no clinical method to determine which of these patients will progress to AD with dementia, and which will not. The AD profile discovered in this study using the SELDI ProteinChip technology may be a major breakthrough as a method to help clinicians identify AD very early in the disease process. This may have a large impact if the new drugs aimed at slowing down the degenerative process (e.g. beta-amyloid vaccination regimes and secretase inhibitors) prove to have a beneficial clinical effect, since they will probably be most effective before neurodegeneration is too severe."

Ciphergen has filed a patent application that covers the use of the novel biomarkers and biomarker patterns for diagnosis of Alzheimer’s disease.

About Ciphergen
Ciphergen develops, manufactures and markets a family of ProteinChip® Systems and services for clinical, research and process proteomics applications, as well as a broad range of bioseparations media for protein purification through its BioSepra process chromatography division. ProteinChip Systems and Biomarker Discovery Center® collaborative services enable protein discovery, profiling, characterization and assay development to provide researchers with predictive analysis capabilities and a better understanding of biological functions at the protein level. ProteinChip Systems are enabling tools in the emerging field of protein-based biology research, known as proteomics. Proteomics provides a direct approach to understanding the role of proteins in the biology of disease, monitoring disease progression and evaluating the therapeutic effects and side effects of drugs. Ciphergen believes proteomics will be a major focus of biological research by enhancing the understanding of gene function and the molecular basis of disease. Additional information about Ciphergen can be found at www.ciphergen.com.

Safe Harbor Statement
Note Regarding Forward-Looking Statements: For purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”), Ciphergen disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples of such forward-looking statements include statements regarding the use of ProteinChip technology to discover useful protein biomarkers and develop diagnostic assays for Alzheimer’s Disease, and future growth in the field of proteomics. Actual results may differ materially from those projected in such forward-looking statements due to various factors, including the ProteinChip technology’s ability to validate and/or develop these protein biomarkers as diagnostic assays, and the continued emergence of proteomics as a major focus of biological research and drug discovery. Investors should consult Ciphergen’s filings with the Securities and Exchange Commission, including its Registration Statement on Form S-3 dated October 8, 2003, for further information regarding these and the other risks of the Company's business.

Ciphergen, ProteinChip, Biomarker Discovery Center and BioSepra are registered trademarks of Ciphergen Biosystems, Inc.
For more information contact:

Sue Carruthers
Investor Relations
Ciphergen Biosystems, Inc.
510 505-2100

WWW: http://www.ciphergen.com/

Message posted by: Frank S. Zollmann

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