FREMONT, Calif., July 22 /PRNewswire-FirstCall/ -- Ciphergen Biosystems, Inc. announced today that Prof. Kaj Blennow from the University of Gothenburg presented encouraging data from a comprehensive clinical study of human cerebral spinal fluid (CSF) comparing very mild Alzheimer's Disease patients with normal individuals and non-AD dementia controls comprising a total of 236 samples. Scientists at Ciphergen's Diagnostics Division discovered over 40 biomarkers that were either increased or decreased in Alzheimer's Disease and considered statistically meaningful. These biomarkers encompass many different aspects of AD neuropathology which make them potentially useful for further research into disease mechanism. Using multi-biomarker combinations, initial assays were developed that yielded diagnostic performance of approximately 86% accuracy in detecting early stage Alzheimer's Disease. Such assays, when confirmed in validation studies, may prove useful to physicians in differentiating AD from other forms of dementia as well as by pharmaceutical companies for therapeutic monitoring assays in both pre-clinical and clinical development. Follow-on studies are underway in CSF and serum samples of pathology confirmed cases.
Prof. Blennow stated, "SELDI is a powerful method in the search for CSF biomarkers and it picked up biomarkers previously missed by other proteomic methods. We have generated promising results both for Alzheimer's Disease and Frontotemporal Dementia, and are identifying proteins clearly linked to the pathogenesis."
"Ciphergen's Diagnostics Division fully intends to pursue translating these novel biomarkers into multi-biomarker SELDI-based assays for the diagnosis and treatment monitoring of Alzheimer's Disease," stated Gail S. Page, President of Ciphergen's Diagnostics Division.
Working with collaborators and well characterized sample collections from the University of Kuopio and Sahlgren's University Hospital, in approximately 4 months a scientific team from Ciphergen Diagnostics' Biomarker Discovery Center(R) laboratory in Copenhagen discovered 44 biomarkers (P<0.001) which either increased (37) or decreased (7) in AD relative to control non-AD samples. Over 20 biomarkers have been purified, sequenced and characterized using Ciphergen's ProteinChip(R) System. The markers characterized in this study are linked with many different aspects of AD neuropathology including plaque and tangle formation, neurodegeneration including synaptic loss, neurotransmitter dysfunction, lipid metabolism, inflammation including microglia activation, insulin signaling, iron metabolism and oxidative stress. Some of the markers overlap with known markers from the literature while others are completely novel full length protein markers or biologically relevant processed forms previously not detected by other proteomic methods (e.g. 2D-PAGE, LC/MS) and hypothesis driven studies.
Given there is no one pathological process specific for AD, diagnostic development strategies based on the measurement of single markers is unlikely to produce clinically useful performance, particularly for differential diagnosis. The research team applied Ciphergen's Biomarker Patterns(TM) Software (BPS) to select critical combinations of biomarkers to discriminate early stage AD from control individuals; a resulting multi-biomarker assay yielded diagnostic performance of approximately 86% accuracy in detecting early stage Alzheimer's Disease.
The research team is planning to test the same biomarker panel and multivariate marker combinations in pathology confirmed and long term followed longitudinal cases to more accurately assess assay performance. Working with its collaborators, Ciphergen's Diagnostics Division is also in the process of building SELDI-based immunoassays to a sub-set of the CSF markers in order to monitor diagnostically relevant processed forms in blood.
About Ciphergen
Ciphergen's Diagnostics Division is dedicated to the discovery of protein biomarkers and panels of biomarkers and their development into protein molecular diagnostic tests that improve patient care; and to providing collaborative R&D services through its Biomarker Discovery Center(R) laboratories for biomarker discovery for new diagnostic tests as well as pharmacoproteomic services for improved drug toxicology, efficacy and theranostic assays. Ciphergen's Biosystems Division develops, manufactures and markets a family of ProteinChip(R) Systems and services for clinical, research, and process proteomics applications, as well as a broad range of bioseparations media for protein purification and large scale production. ProteinChip Systems enable protein discovery, characterization, identification and assay development to provide researchers with predictive, multi-marker assay capabilities and a better understanding of biological function at the protein level. Additional information about Ciphergen can be found at http://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 biomarkers discovered by Ciphergen that may prove useful for research into Alzheimer's Disease research or to differentiate Alzheimer's Disease from other dementias or to monitor treatment response, the use of ProteinChip technology to discover useful protein biomarkers that can act as novel drug targets or disease markers, develop and commercialize clinical diagnostics that improve patient care, the ability to provide services that lead to improved toxicology assays and diagnostic assays, and statements regarding our Diagnostics Division. Actual results may differ materially from those projected in such forward-looking statements due to various factors, including the possibility that biomarkers discovered in Ciphergen's Alzheimer's Disease program may fail to validate in larger studies as either providing useful disease mechanism insights or as accurate diagnostics, the ProteinChip technology's ability to validate and/or develop protein biomarkers as novel drug targets, diagnostic or toxicology assays, and the Company's ability to successfully commercialize such tests. Investors should consult Ciphergen's filings with the Securities and Exchange Commission, including its Form 10-Q dated May 10, 2004 and amended May 20, 2004, for further information regarding these and other risks of the Company's business.
NOTE: Ciphergen, ProteinChip, Biomarker Discovery Center and BioSepra are registered trademarks of Ciphergen Biosystems, Inc.
Ciphergen Biosystems, Inc.CONTACT: Sue Carruthers, Investor Relations of Ciphergen Biosystems,Inc., +1-510-505 2297
Web site: http://www.ciphergen.com/