FREMONT, Calif., Oct. 6 /PRNewswire-FirstCall/ -- Ciphergen Diagnostics, a division of Ciphergen Biosystems, Inc. , presented yesterday initial results of its ongoing study to validate biomarkers for ovarian cancer and reported progress in assay development at the meeting of the International Gynecologic Cancer Society in Edinburgh. In a study utilizing 436 samples derived from 53 women with early-stage ovarian cancer (stage I-II), 116 women with late-stage ovarian cancer, and 98 control women, Ciphergen and its collaborators confirmed the down-regulation of specific variants of transthyretin and apolipoprotein A1, two markers Ciphergen has previously reported to be down-regulated in early stage ovarian cancer. This study was done in collaboration with Professor Ate van der Zee, of University Hospital Groningen, and Professor Ignace Vergote, of Universitaire Ziekenhuizen K.U.Leuven.
“These results confirm our recently published findings, revealing the reproducibility of the markers, when discovered using a rigorous study design,” said Gail S. Page, President of Ciphergen’s Diagnostics Division. “In addition, these results were achieved using a newly developed assay specifically designed for these markers and read on our new instrument, the ProteinChip(R) System 4000. This is one of the milestones we have set for ourselves in the clinical development process.”
Ciphergen Diagnostics developed a chromatographic SELDI-based assay in which five transthyretin variants could be assayed on a Q10 ProteinChip array and two apolipoprotein A1 variants could be assayed on an IMAC ProteinChip array. The arrays were read on the new PCS4000. These assays achieve CV’s of <15%. The levels of various forms of transthyretin were decreased in women with either late-stage (p<10-10) or early stage (p<10-4) ovarian cancer compared to controls. The levels of various forms of apolipoprotein A1 were decreased in women with either late-stage (p<10-3) or early-stage (p<10-2) ovarian cancer compared to controls.
In addition, data were shown indicating that these markers were responsive to therapy. Levels of transthyretin and apolipoprotein A1 variants were increased after surgical treatment for women with either late-stage or early-stage disease. In a subset of women whose levels were followed until recurrence, both transthyretin and apolipoprotein A1 variants decreased at or before clinical recurrence was detected.
“These findings suggest that these markers may be useful for multiple clinical applications, including to aid in the initial diagnosis and staging of ovarian cancer, as well as to monitor response to therapy and for recurrence,” commented Dr. Eric Fung, M.D., Ph.D., VP of Clinical Affairs. “We are expanding our studies to provide additional clinical and statistical support for these conclusions.”
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 the utility of these biomarkers for multiple clinical applications, including to aid in the initial diagnosis and staging of ovarian cancer, as well as to monitor response to therapy and for recurrence, the planned expansion of studies, 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 the biomarker assay described at this scientific meeting or any other biomarker panel discovered by Ciphergen may fail to validate in larger studies as providing an accurate diagnostic for ovarian cancer, 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 August 9, 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: investor relations, Sue Carruthers of Ciphergen Biosystems,Inc., +1-510-505-2297
Web site: http://www.ciphergen.com/