Ciphergen Initiates Clinical Trial for Ovarian Cancer Triage Test
February 13 2007 - 9:08AM
PR Newswire (US)
FREMONT, Calif., Feb. 13 /PRNewswire-FirstCall/ -- 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. DATASOURCE: Ciphergen Biosystems, Inc. CONTACT:
Sue Carruthers, Investor Relations, Ciphergen Biosystems, Inc.,
+1-510-505-2233; or Lori Murray of WeissComm Partners,
+1-415-946-1070, or Ciphergen Biosystems, Inc. Web site:
http://www.ciphergen.com/
Copyright
Ciphergen Biosystems (NASDAQ:CIPH)
Historical Stock Chart
From Oct 2024 to Oct 2024
Ciphergen Biosystems (NASDAQ:CIPH)
Historical Stock Chart
From Oct 2023 to Oct 2024