Ciphergen Engages PrecisionMed, Inc. as Clinical Trial CRO for Ovarian Tumor Triage Test Clinical Trials
15 Dezembro 2006 - 12:00PM
PR Newswire (US)
FREMONT, Calif., Dec. 15 /PRNewswire-FirstCall/ -- Ciphergen
Biosystems, Inc. (NASDAQ:CIPH) today announced that it has selected
PrecisionMed, Inc., a contract research organization (CRO) with
expertise in the collection and management of human biological
samples. PrecisionMed will support Ciphergen in its upcoming
clinical trials for its ovarian tumor triage test, including the
Ovarian PC1 Biomarker Clinical Trial. "Based on the positive
results of our preclinical testing, we are moving forward with a
prospective clinical trial for submission to the U.S. Food and Drug
Administration (FDA). The selection of a CRO to support our ovarian
tumor triage test clinical trial program is an important milestone
in our product development efforts," said Gail S. Page, President
and CEO of Ciphergen. "We selected PrecisionMed because it will
assist us in executing a high-quality, cost-effective clinical
program." PrecisionMed will perform the study setup, protocol
review, site recruitment, site monitoring, and project management
of Ciphergen's clinical trials. "We are pleased to partner with
Ciphergen on their clinical program for the ovarian tumor triage
test," said John Flax, M.D., President and CEO of PrecisionMed.
"There is a critical need for new blood tests that can provide
information describing the likelihood that an ovarian tumor is
malignant." 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. Ciphergen is undertaking a prospective clinical trial to
support submission to the FDA for clearance as an in vitro
diagnostic. 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 the positive impact of Ciphergen's partners on its
clinical programs. Actual results may differ materially from those
projected in such forward-looking statements due to various
factors, including the possibility that the partnership may not
develop as expected. 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. NOTE:
Ciphergen is a registered trademark of Ciphergen Biosystems, Inc.
DATASOURCE: Ciphergen Biosystems, Inc. CONTACT: investors, Sue
Carruthers of Ciphergen Biosystems, Inc., +1-510-505-2233; or
media, Daryl Messinger of WeissComm Partners, +1-415-999-2361, for
Ciphergen Biosystems, Inc. Web site: http://www.ciphergen.com/
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