FREMONT, Calif., Oct. 24 /PRNewswire-FirstCall/ -- Vermillion, Inc. today announced that it 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. 550 patients were enrolled at 27 clinical trial sites.
“Enrollment completion marks a significant milestone for our company, our ovarian cancer diagnostics program, our shareholders and for potential patients who may benefit from improved treatment when diagnosed with a pelvic mass,” said Gail S. Page, President and CEO, Vermillion, Inc. “We are now compiling these data for submission to the FDA for in vitro diagnostic clearance and expect to report top-line results in December.”
Studies show that women with ovarian cancer who are initially operated on by a gynecologic oncologist or at specialist medical centers survive longer and have a better chance of being cured, compared to those whose surgeries are performed by a non-specialist. The ovarian tumor triage test is designed to assist physicians in determining whether patients should be referred to specialists prior to their initial surgery.
About Vermillion’s Ovarian Cancer Diagnostic Program
In addition to developing a diagnostic test designed to distinguish between benign and malignant pelvic masses, Vermillion has multiple ovarian cancer diagnostic tests in development. 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
Commonly known as the “silent killer,” ovarian cancer leads to approximately 15,000 deaths each year in the United States, according to the American Cancer Society. 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 the risks and uncertainties discussed in Vermillion’s Form 10-K for the year ended Dec. 31, 2006, and in Vermillion’s periodic reports on Form 10-Q and Form 8-K. Vermillion is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.
Forward-looking statement cannot be guaranteed and actual results may differ materially from those Vermillion projects. Discovery or identification of new protein biomarkers cannot be guaranteed and the ultimate outcome of our ovarian cancer diagnostics program and clinical trial are unknown. Future approvals by the FDA or foreign regulatory authorities regarding our product candidates are uncertain. You are encouraged to read Vermillion’s reports filed with the U.S. Securities and Exchange Commission, available at http://www.sec.gov.
CONTACT: Sue Carruthers of Vermillion, Inc., +1-510-505-2297; or Lori
Murray of WeissComm Inc., +1-415-946-1070, for Vermillion, Inc.
Web site: http://www.vermillion.com/
