FREMONT, Calif., and BERLIN, Oct. 31 /PRNewswire-FirstCall/-- Vermillion, Inc. and its collaborators presented data demonstrating that several of Vermillion’s ovarian cancer protein biomarkers could be used to detect early-stage ovarian cancer and to predict survival. These poster presentations were made at the 15th International Meeting of the European Society of Gynecological Oncology (ESGO) in Berlin, Germany.
The ovarian cancer detection study showed that a panel of biomarkers in combination with CA125 could more accurately identify early stage ovarian cancer than could CA125 alone. CA125 is a commonly used tumor marker for ovarian cancer. For stage I disease, the combination correctly identified 80 percent of the cancers while CA125 predicted 68 percent. Similarly with stage II ovarian cancer, the Vermillion panel with CA125 identified 88 percent of the cancers compared to 71 percent for CA125:
The study analyzed pre-operative serum samples from 231 patients. Vermillion collaborated with Robert C. Bast, Jr., M.D. and colleagues from the University of Texas M.D. Anderson Cancer Center on this research.
“Ovarian cancer is the most lethal of gynecologic malignancies, and the development of a reliable test for detecting early-stage ovarian cancer could contribute to improving overall survival in patients,” said Dr. Bast, Vice President for Translational Research and the Harry Carothers Wiess Distinguished University Chair for Cancer Research at the University of Texas M.D. Anderson Cancer Center. “These discoveries promise to improve the ability of blood tests to detect women with early ovarian cancer.”
In the survival study, researchers determined that Vermillion’s seven biomarker panel could accurately and with statistical significance predict women with ovarian cancer who had good prognosis from those who did not. The study used Kaplan-Meier analysis to show that women with a low panel score were significantly more likely to survive than women with high scores, independent of the stage of the disease (Mantel-Cox p value = 0.002). Researchers analyzed pre-operative serum samples from 84 patients diagnosed with invasive epithelial ovarian cancer. Vermillion collaborated with researchers from the Oncologic Clinic Rigshospitalet, University of Copenhagen and the Danish Cancer Society on this study.
“These data further contribute to our robust ovarian cancer diagnostics pipeline, and validation studies are underway in a larger population of women
with ovarian cancer with the goal of replicating these results,” said Eric T. Fung, M.D., Ph.D., Chief Scientific Officer, Vermillion, Inc.
In addition to these data at ESGO, Vermillion is presenting results supporting the use of ovarian cancer triage test to distinguish benign from malignant ovarian tumors.
About Vermillion’s Ovarian Cancer Diagnostic Program
In addition to the data presented at ESGO, Vermillion has multiple ovarian cancer diagnostic tests in development. Vermillion has completed clinical trial enrollment for its ovarian cancer triage test. The prospective clinical trial was designed to demonstrate that the ovarian triage test is a useful adjunct for distinguishing benign from malignant ovarian tumors. Studies are underway to predict recurrence of ovarian cancer and a test to aid physicians in identifying women considered at high risk for ovarian cancer.
Vermillion’s comprehensive diagnostic development program is being conducted with several leading collaborators at The Johns Hopkins School of Medicine, The University of Texas M.D. Anderson Cancer Center, University College London, and the University of Kentucky.
About Ovarian Cancer
Ovarian cancer leads to approximately 15,000 deaths each year in the United States, according to the American Cancer Society. Most women with ovarian cancer do have symptoms, but they are not specific for the disease and occur much more frequently with benign gastrointestinal, urologic and gynecologic conditions. Approximately 20,000 new cases are diagnosed each year, with the majority in patients diagnosed with late stage disease where the cancer has spread beyond the ovary. The prognosis is poor in these patients, leading to the high mortality from this disease. A diagnostic test is needed that can provide adequate predictive value to stratify patients with a pelvic mass into high risk of invasive ovarian cancer versus those with low risk, as well as a screening test for the diagnosis of early-stage ovarian cancer, which is essential for improving overall survival in patients. Ovarian cancer has up to a 90% cure rate following surgery and/or chemotherapy if detected in stage 1.
About Vermillion, Inc.
Vermillion, Inc. is dedicated to the discovery, development and commercialization of novel high-value diagnostic tests that help physicians diagnose, treat and improve outcomes for patients. Vermillion, along with its prestigious scientific collaborators, has ongoing diagnostic programs in oncology/hematology, cardiology and women’s health with an initial focus in ovarian cancer. Based in Fremont, California, more information about Vermillion can be found on the Web at http://www.vermillion.com.
Forward Looking Statements
This news release contains forward-looking statements that involve significant risks and uncertainties, including statements regarding Vermillion’s plans, objectives, expectations and intentions. These forward- looking statements are based on Vermillion’s current expectations. The Private Securities Litigation Reform Act of 1995 provides a “safe harbor” for such forward-looking statements. In order to comply with the terms of the safe harbor, Vermillion notes that a variety of factors could cause actual results and experience to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. Factors that could cause actual results to materially differ include but are not limited to: (1) uncertainty in obtaining intellectual property protection for inventions made by Vermillion; (2) unproven ability of Vermillion to discover, develop, and commercialize diagnostic products based on findings from its disease association studies; (3) unproven ability of Vermillion to discover or identify new protein biomarkers and use such information to develop ovarian cancer diagnostic products; (4) uncertainty as to whether Vermillion will be able to obtain any required regulatory approval of its diagnostic products; (5) uncertainty of market acceptance of its products, including the risk that its products will not be competitive with products offered by other companies, or that users will not be entitled to receive adequate reimbursement for its products from third party payors such as private insurance companies and government insurance plans; and (6) other factors that might be described from time to time in Vermillion’s filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Vermillion expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in Vermillion’s expectations or any change in events, conditions or circumstances on which any such statement is based, unless required by law.
Sue Carruthers Daryl Messinger
Vermillion, Inc. WeissComm, Inc.
510 505 2297 415 946 106
CONTACT: Sue Carruthers of Vermillion, Inc., +1-510-505-2297; or Daryl
Messinger of WeissComm, Inc., +1-415-946-1062
Web site: http://www.vermillion.com//
