- Multiple Studies Presented at Society of Gynecologic Oncologists' Annual
Meeting on Women's Cancer -
FREMONT, Calif. and TAMPA, Fla., March 10 /PRNewswire-FirstCall/ -- Vermillion, Inc. (Nasdaq: VRMLD), a molecular diagnostics company, presented data from several studies demonstrating the benefits of the Company's ovarian cancer protein biomarker panel. The data suggest that use of Vermillion's biomarkers could help better identify women with ovarian cancer, as well as improve the detection of early-stage disease. Results of these studies were presented at the Society of Gynecologic Oncologists' (SGO) 39th Annual Meeting on Women's Cancer in Tampa, Florida (Posters 080, 135, 175).
"The data presented today continue to confirm the potential of our biomarkers to distinguish between benign and malignant tumors and diagnose early-stage disease," said Eric T. Fung, M.D., Ph.D., Chief Scientific Officer of Vermillion.
Further Evidence Supporting Ovarian Tumor Triage Test (Poster 135)
A clinical study examining Vermillion's marker panel for ovarian cancer provided independent validation that it can distinguish malignant tumors from benign pelvic masses. Results of the study demonstrated that the biomarker panel could more than double the number of ovarian cancer cases referred to a gynecologic oncologist, thereby improving survival rates and reducing the number of surgeries performed.
A model comprising the Company's biomarker panel was trained on a set of 270 samples from the University of Kentucky. This model was then tested in a prospectively collected cohort of 709 women from Rigshospitalet in Copenhagen, Denmark. Vermillion's model demonstrated portability from the training set to the validation set, which is a critical step in diagnostic test development.
Positive Results in Early-Stage Disease Detection (Poster 080)
The ovarian cancer detection study showed that Vermillion's panel of biomarkers in combination with CA-125 could more accurately identify early- stage ovarian cancer than could CA-125 alone. CA-125 is the only tumor marker for ovarian cancer currently available on the market; however, it is not cleared for early-stage disease detection. When examining stage-1 disease, the combination of the two markers correctly identified 87 percent of the cancers.
The study trained a model on pre-operative serum samples from 231 patients, and then tested the model on pre-operative serum samples from 450 patients. Vermillion worked in collaboration with Robert C. Bast, Jr., M.D. and colleagues from the University of Texas M.D. Anderson Cancer Center on this research.
New Ovarian Biomarkers on the Horizon (Poster 175) Another study found that calgranulin A and B, two proteins commonly found in malignant ovarian cysts, may be useful in helping diagnose and predict prognosis of ovarian cancer.
Researchers at Vermillion and the University of Kentucky Chandler Medical Center used surface enhanced laser desorption ionization time-of-flight mass spectrometry (SELDI-TOF) to analyze ovarian cyst fluids and identify the underlying proteins that could serve as potentially useful biomarkers for ovarian cancer. Fluids from benign (n=45), malignant (n=15), and low malignant potential (n=13) ovarian tumors were examined. The calgranulin proteins were increased in malignant ovarian cyst fluids as compared to benign cyst fluids (p<0.001).
About Vermillion's Ovarian Cancer Diagnostic Program
Vermillion has multiple ovarian cancer diagnostic tests in development. The most advanced of Vermillion's programs is the Ovarian Tumor Triage Test, which utilizes a panel of biomarkers to help identify women with cancer so they can be referred to a gynecologic oncologist for their initial surgery. Vermilion intends to submit clinical trial data on the Ovarian Tumor Triage
Test to the U.S. Food and Drug Administration for clearance as an in vitro diagnostic test in the first half of 2008.
Additionally, studies are underway to detect early-stage ovarian cancer, predict prognosis and recurrence, and identify women considered at high-risk for the disease.
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, Rigshospitalet (Copenhagen), and the University of Kentucky.
About Ovarian Cancer
According to the American Cancer Society (ACS), approximately 22,430 new cases of ovarian cancer will be diagnosed this year, and 15,280 deaths will be reported as a result of the disease. When diagnosed at its earliest stages, ovarian cancer has a 5-year survival rate of 93 percent. However, only 19 percent of ovarian cancers are diagnosed before the tumor has spread outside the ovary. For late-stage disease, the 5-year survival rate falls to 18 percent.
New diagnostic tests are needed 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 percent cure rate following surgery and/or chemotherapy if detected in stage 1.
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 diagnostic programs in oncology, hematology, cardiology and women's health. Vermillion is based in Fremont, California. Additional 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. There are no guarantees that Vermillion will succeed in its efforts to commercialize its ovarian cancer diagnostic tests in 2008 or during any other period of time. 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.
|SOURCE Vermillion, Inc.|
Copyright©2008 PR Newswire.
All rights reserved