Ciphergen Initiates Clinical Trial For Ovarian Cancer Triage Test

Main Category: Ovarian Cancer
Also Included In: Cancer / Oncology;  Clinical Trials / Drug Trials
Article Date: 14 Feb 2007 - 0:00 PDT

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Ciphergen Biosystems, Inc. (Nasdaq: CIPH) today announced the initiation of a prospective clinical trial to evaluate its ovarian cancer triage test to differentiate women with ovarian cancer from women with benign pelvic masses.

"Physicians currently have no reliable way to distinguish between a benign and malignant ovarian tumor prior to performing surgery for a known pelvic mass," said Frederick R. Ueland, MD, Associate Professor of Obstetrics and Gynecology, Division of Gynecologic Oncology at the Markey Cancer Center at the University of Kentucky and Principal Investigator for the study. "This triage test could help identify women with ovarian cancer so they can be referred directly to a gynecological oncologist for treatment. Studies have shown that women with ovarian cancer have an improved median survival of six to nine months when their initial surgery is performed by a gynecological oncologist compared to a general surgeon. This triage test could potentially reduce the number of surgeries performed by seeing the appropriate specialist first." The University of Kentucky is the first clinical trial site to begin enrollment.

The trial seeks to demonstrate that the positive predictive value of the Ciphergen ovarian triage test is better than the current standard of care -- physical and radiological exam -- for distinguishing benign from malignant ovarian tumors. Depending on prevalence of cancer within the study population, Ciphergen plans to enroll 700-1,000 patients at approximately 20 clinical trial sites. Ciphergen expects to submit the results of the trial to the U.S. Food and Drug Administration for clearance as an in vitro diagnostic. Enrollment information will be available on http://clinicaltrials.gov/ beginning Wednesday, February 14, 2007.

"Based on the promising results of earlier studies, we are advancing our ovarian cancer triage test into clinical trials in preparation for our submission to the FDA for in vitro diagnostic clearance," said Eric T. Fung, M.D., Ph.D., Chief Scientific Officer for Ciphergen. "Physicians need a blood test that can help stratify patients with a pelvic mass into higher or lower risk for ovarian cancer."

About Ciphergen's Ovarian Cancer Diagnostic Program

Ciphergen has an advanced diagnostic program in ovarian cancer and has developed a panel of biomarkers that provides risk stratification information for ovarian cancer based on a series of studies involving over 2,000 clinical samples from more than five sites. PrecisionMed, Inc., a contract research organization (CRO) with expertise in the collection and management of human biological samples, is supporting Ciphergen in the clinical trial for its ovarian tumor triage test.

Ciphergen has a strategic alliance with Quest Diagnostics focused on commercializing the ovarian tumor triage test. Quest also has the option to develop and commercialize two additional Ciphergen tests.

In addition to developing a diagnostic test designed to distinguish between benign and malignant pelvic masses, studies are underway to predict recurrence of ovarian cancer and to provide additional tools to aid physicians in triaging women considered at high risk of ovarian cancer. Ciphergen'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 14,000 deaths each year in the United States. Approximately 23,000 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.

About Ciphergen

Ciphergen Biosystems, 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. Ciphergen, along with its prestigious scientific collaborators, has ongoing diagnostic programs in oncology, cardiology and women's health with an initial focus in ovarian cancer. Based in Fremont, California, more information about Ciphergen can be found on the Web at http://www.ciphergen.com.

Safe Harbor Statement

Note Regarding Forward-Looking Statements: This press release contains 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 potential benefits of Ciphergen's ovarian cancer triage test. Actual results may differ materially from those projected in such forward-looking statements due to various factors, including the possibility that the clinical trial to evaluate the ovarian cancer triage test may have unexpected or negative results. Investors should consult Ciphergen's filings with the Securities and Exchange Commission, including its Form 10-Q filed November 20, 2006, for further information regarding these and other risks related to the Company's business.

Ciphergen Biosystems, Inc.
http://www.ciphergen.com