Ciphergen Presents Promising Validation Results for Ovarian Cancer Biomarkers at International Gynecologic Cancer Society Meeting
FREMONT, Calif., Oct. 6 /PRNewswire-FirstCall/ -- Ciphergen Diagnostics, a division of Ciphergen Biosystems, Inc. (Nasdaq: CIPH - News), 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® 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." |
