CIPH Ciphergen Biosystems (MM)

Johns Hopkins Researchers Use ProteinChip(R) Technology to Discover Novel Biomarkers for the Potential Diagnosis of Pancreatic Cancer Data Presented in the Journal of Clinical Cancer Research FREMONT, Calif., Feb. 6 /PRNewswire-FirstCall/ -- Ciphergen Diagnostics, a division of Ciphergen Biosystems, Inc. announced today that a research team led by Drs. Michael Goggins and Daniel W. Chan at The Johns Hopkins University School of Medicine used the company's ProteinChip(R) technology to discover panels of novel serum biomarkers that are able to differentiate patients with pancreatic cancer from patients with other pancreatic diseases and from healthy individuals. The study was published today in the Journal of Clinical Cancer Research. "Ciphergen's clinical diagnostics program, based on our core SELDI ProteinChip technology, is enabling researchers to rapidly advance the prospect of highly sensitive, specific and non-invasive tests for numerous cancers as well as several other diseases," said Gail Page, President of Ciphergen Diagnostics. "We believe that novel biomarkers can enable early detection of pancreatic cancer and this program is one we will be pursuing, in partnership with our collaborators at The Johns Hopkins University School of Medicine, as part of our emerging diagnostic pipeline." Using SELDI ProteinChip technology and bioinformatics tools, Dr. Goggins and colleagues analyzed serum samples from 60 patients with pancreatic cancer, 60 age- and sex-matched patients with non-malignant pancreatic diseases and 60 age- and sex-matched healthy patients in the controls group. Analysis of the data revealed two protein biomarkers that could discriminate pancreatic cancer patients from healthy controls with specificity (true negatives) of 97% and sensitivity (true positives) of 78%. The addition of CA19-9 to the two-marker panel further improved its overall performance. Because the study analyzed patients with surgically resectable cancer, it is possible that this marker panel will be diagnostically useful even for patients with small cancers. Ciphergen's Diagnostics Division and the Johns Hopkins research team are currently recruiting additional patients in order to perform follow-on validation studies. Pancreatic cancer is the fifth leading cause of cancer death and has the poorest survival rate for any solid cancer. The American Cancer Society projects that, in 2004, about 31,860 people in the U.S. will be found to have pancreatic cancer and about 31,270 will die of the disease. The disease is often very advanced by the time symptoms occur and diagnosis is established, as a result of which the five year survival rate of pancreatic cancer patients is less than 5%. If detected early and treated by surgery, 5-year survival rates improve to approximately 15-40%. Thus, there is an unmet clinical need for accurate non-invasive tests for the early detection of pancreatic cancer. A currently available serum test, CA19-9, can be used for monitoring patients already diagnosed with pancreatic cancer, but there is no serum test today for the initial diagnosis of pancreatic cancer. Ciphergen and The Johns Hopkins University School of Medicine have been collaborating since 2000 focusing on the discovery of novel protein biomarkers of various cancers. As part of the collaboration, Ciphergen has provided financial support and technical assistance through its Biomarker Discovery Center(R) facilities. Ciphergen has an exclusive option to the therapeutic and diagnostic rights to discoveries made under the collaboration, with royalties back to Johns Hopkins. Patents have been filed on the novel biomarkers described in the Journal of Clinical Cancer Research paper. 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) facilities 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 BioSepra(R) 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 the potential use of the marker panel reported in the Journal of Clinical Cancer Research as a diagnostic test for patients with pancreatic cancer or small cancers, the use of ProteinChip technology to discover useful protein biomarkers, develop and commercialize protein molecular diagnostics that improve patient care, and the ability to provide services that lead to improved toxicology assays and diagnostic assays. Actual results may differ materially from those projected in such forward-looking statements due to various factors, including the risk that the marker panels reported in the Journal of Clinical Cancer Research do not validate over larger populations or can not be developed into clinically useful diagnostic tests, the ProteinChip technology's ability to validate and/or develop protein biomarkers as diagnostic or toxicology assays, and Ciphergen's ability to successfully commercialize any such tests. Investors should consult Ciphergen's filings with the Securities and Exchange Commission, including its Form 10-Q dated November 14, 2003, for further information regarding these and the other risks of the Company's business. NOTE: Ciphergen, ProteinChip, BioSepra and Biomarker Discovery Center are registered trademarks of Ciphergen Biosystems, Inc. DATASOURCE: Ciphergen Biosystems, Inc. CONTACT: Sue Carruthers, Investor Relations of Ciphergen Biosystems, Inc., +1-510-505-2297 Web site: http://www.ciphergen.com/

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