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First Subjects Enrolled in Epigenomics sponsored PRESEPT Colorectal
Cancer Screening Study |
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Multi-center study in U.S. and Germany enrolling up to 7,500
individuals aims at demonstrating the benefits of colorectal cancer
population screening with Epigenomics' Septin 9 blood test
Berlin, Germany, and Seattle, WA, USA, June 30, 2008 - Epigenomics AG
(Frankfurt Prime Standard: ECX), a molecular diagnostics company
focusing on the development and commercialization of products for
cancer detection based on DNA methylation, today announced the
enrollment of the first subjects in the PRESEPT study.
"We are excited that our PRESEPT study is now well under way as
scheduled. PRESEPT is a unique endeavor: It is one of the largest
colorectal cancer screening studies ever, and is the first to
prospectively evaluate a molecular marker for blood-based colorectal
cancer screening", commented Geert Nygaard, Chief Executive Officer
of Epigenomics. "The study will support the imminent clinical
validation and commercial launch of our partners' diagnostics tests
based on our biomarker and technology. The PRESEPT study is a great
leap forward in the realization of our vision of detecting cancers
based on DNA methylation patterns with a standard blood test."
PRESEPT is a multi-center, multi-national clinical study sponsored by
Epigenomics prospectively evaluating the clinical performance of
Epigenomics' proprietary biomarker, Septin 9, for colorectal cancer
population wide screening of guideline-eligible individuals. With the
data generated in the PRESEPT study, Epigenomics intends to
demonstrate that colorectal cancer early detection with a blood test
based on Septin 9 will meet the requirements of current U.S.
screening guidelines for non-invasive screening tests. To support
future coverage by health insurers, the performance characteristics
established in PRESEPT will be used to determine the potential health
economic benefit of blood based colorectal cancer screening using a
validated model developed by Uri Ladabaum, M.D., M.S., University of
California, San Francisco, CA. Further, Epigenomics will provide
industry partners developing Septin 9 IVD tests access to the PRESEPT
samples and data to perform pivotal clinical trials necessary to
obtain regulatory approvals.
The study is planned to enroll up to 7,500 asymptomatic subjects with
average to increased risk for colorectal cancer aged 50 or older that
are scheduled for a regular screening colonoscopy at 12 to 14
clinical sites in the U.S. and Germany. This population is expected
to harbor about 50 cases of undetected colorectal cancer. For each
subject, blood samples are collected prior to bowel prep for
colonoscopy and analyzed for methylated Septin 9 DNA by Epigenomics'
partner Quest Diagnostics. The results of Septin 9 testing are
compared to the data obtained by colonoscopy, the gold standard for
definitive colorectal cancer diagnosis. For the cases where polyps or
cancerous lesions are identified during colonoscopy, further clinical
and pathological data will be included in the classification of
disease.
As a first site participating in PRESEPT, the Regional
Gastroenterology Associates, Lancaster, PA, with site principal
investigator Dr. Raymond Foley, began enrolling subjects last week.
Further sites in the U.S. and Germany are planned to be initiated in
the next few weeks. Enrollment is scheduled to ramp up to yield
sufficient subjects for an interim analysis in Q1 2009. The final
results of PRESEPT are expected during H2 2009.
In accordance with FDA guidance, Epigenomics established a Clinical
Study Steering Committee to oversee the study and assure that it is
conducted according to all applicable ethical and quality standards.
The committee is chaired by David Ransohoff, M.D., University of
North Carolina School of Medicine, Chapel Hill, NC. Other members of
the committee include Neal K. Osborn, M.D., M.Sc., and Timothy R.
Church, Ph.D., principal investigators for PRESEPT at Atlanta
Gastroenterology, Atlanta, GA and the University of Minnesota,
Minneapolis, MN, respectively, and Robert W. Day, M.D., Ph.D.
President Emeritus of The Fred Hutchinson Cancer Research Center,
Seattle, WA. Also, Brent Blumenstein, Ph.D., of Trial Architecture
Consulting, Seattle, WA, was assigned as independent biostatistician.
Epigenomics will be represented on the committee by the PRESEPT Study
Director, Michael Wandell, Pharm.D., Senior Vice President Regulatory
& Quality, and Cathy Lofton-Day, Ph.D., Vice President Molecular
Biology and PRESEPT Project Manager.
"Adherence to current colorectal cancer screening options poses one
of the greatest challenges to colorectal cancer detection and
treatment. An effective colorectal cancer blood test that could be
integrated into the routine physical examination by the primary care
physician could greatly increase disease detection in asymptomatic
patients. The performance demonstrated for the Septin 9 biomarker in
previous case control studies warrants a thorough, in depth, and
independent analysis of its potential as screening biomarker, and
Epigenomics is putting in motion the elements to make this happen",
explained Prof. David Ransohoff, M.D., PRESEPT Clinical Study
Steering Committee Chair.
The design of the PRESEPT study was developed in close collaboration
with Epigenomics' Medical Advisory Board for Colorectal Cancer
Screening that represents a cross section of primary care physicians
and gastroenterologists with particular expertise in colonoscopy,
colorectal cancer screening, evidence-based medicine, outcomes
research, and health economic analysis.
About Colorectal Cancer Screening
Colorectal cancer is the second leading cause of cancer related death
in the U.S. with an estimated direct medical treatment cost of $8.3
billion in 2007. With a cure rate over 90% if diagnosed in early
stages in the United States, there is now general agreement that
average-risk adults aged 50 and older should be screened for
colorectal cancer. If detected early, individual treatment costs for
colon cancer are estimated at $30,000 per patient, whereas treatment
for a patient who has developed late stage disease is estimated at
$120,000. However, less than 50% of the screening population has had
a recent test. Given today's treatment options for colorectal cancer,
patient outcomes could potentially be greatly improved if more
cancers were detected in early stages.
From a public health as well as a health economics perspective, the
poor adoption of current screening options limits the effectiveness
of colorectal cancer screening initiatives; Current colorectal cancer
screening guidelines include two types of tests, those that detect
polyps and cancer such as colonoscopy and virtual colonoscopy and
those that detect cancer such as the non-invasive stool based tests.
Non-invasive screening is most often conducted using FOBT, which
while inexpensive, exhibits a low compliance rate (around 14% in the
US) due to its use restrictions, perceived inconvenience and lack of
consumer acceptance. The gold standard procedure for colorectal
cancer detection is colonoscopy; it exhibits excellent performance
characteristics, but has a limited utility as a first line screen due
to its high cost, healthcare delivery resource limitations, and
inadequate patient acceptance. It is believed a non-invasive,
convenient, blood-based screening assay capable of detecting
individuals with colorectal disease, confirmed by colonoscopy, would
have greater utility for population screening.
About the Septin 9 Biomarker
The Septin 9 gene encodes a protein involved in cell division and is
thought to play a role in the onset of cancer. Epigenomics has
demonstrated in multiple clinical case control studies with over
3,500 samples from colorectal cancer patients, healthy controls, and
patients with non-cancerous colon diseases that methylated DNA of the
Septin 9 gene shed by tumors into the blood stream can serve as a
biomarker for the sensitive and specific detection of colorectal
cancer. As a first strategic partner, Abbott Molecular, Inc. licensed
the worldwide non-exclusive IVD rights to Epigenomics' proprietary
Septin 9 biomarker for colorectal cancer. In addition, Quest
Diagnostics Inc., the leading provider of diagnostic testing,
information and services, obtained the license to commercialize a
laboratory-developed test (LDT) for Septin 9 in the U.S.
About DNA Methylation
DNA methylation is a natural and tightly controlled biological
process that serves the regulation of genes and the stability of the
human genome. Cytosine, one of the four bases in DNA, can be modified
by the covalent addition of a methyl group. DNA methylation in gene
regulatory regions (i.e. gene promoters) helps control gene activity.
Every cell type has its unique DNA methylation "fingerprint" that
changes in various normal biological processes and in many diseases,
in particular cancer. DNA methylation thus provides a rich source for
highly specific biomarkers for organ-specific disease diagnosis,
classification and prediction for therapeutic intervention.
About Epigenomics AG
Epigenomics is a molecular diagnostics company with a focus on the
development of novel products for cancer. Using DNA methylation
biomarkers, Epigenomics' tests in development aim at diagnosing
cancer at an early stage before symptoms occur and thereby may reduce
mortality from this dreaded disease.
Epigenomics' product pipeline contains a validated biomarker for the
early detection of colorectal cancer in blood plasma, and further
proprietary DNA methylation biomarkers at various stages of
development for prostate and lung cancer detection in body fluids.
Epigenomics' biomarker Septin 9 for the early detection of colorectal
cancer in a simple blood sample demonstrated continuously highest
performance in multiple clinical studies with in total more than
3,500 individuals tested.
For development and global commercialization as in vitro diagnostic
test kits, Epigenomics pursues a non-exclusive partnering strategy
with diagnostics industry companies. As a first strategic partner,
Abbott Molecular Inc. licensed the worldwide non-exclusive IVD rights
to Epigenomics' proprietary Septin 9 biomarker for colorectal cancer.
Epigenomics also aims at giving patients and doctors early access to
these biomarkers through reference laboratory testing services. As a
first reference laboratory partner, Quest Diagnostics Inc., the
leading provider of diagnostic testing, information and services,
obtained the license to commercialize a laboratory-developed test
(LDT) for Septin 9 in the U.S.
Partners in the health care industry and the biomedical research
community can access Epigenomics' portfolio of proprietary DNA
methylation technologies and biomarkers protected by more than 150
patent families through research products, Biomarker Services, IVD
Development Collaborations, and Licensing. The company is
headquartered in Berlin, Germany, and has a wholly owned subsidiary
in Seattle, WA, U.S.A. For more information, please visit
Epigenomics' website at www.epigenomics.com.
###
Disclaimer
This communication expressly or implicitly contains certain
forward-looking statements concerning Epigenomics AG and its
business. Such statements involve certain known and unknown risks,
uncertainties and other factors which could cause the actual results,
financial condition, performance or achievements of Epigenomics AG to
be materially different from any future results, performance or
achievements expressed or implied by such forward-looking statements.
Epigenomics AG is providing this communication as of this date and
does not undertake to update any forward-looking statements contained
herein as a result of new information, future events or otherwise.
Contact:
Epigenomics AG
Dr. Achim Plum
SVP Corporate Development
+49 30 24 345 368
achim.plum@epigenomics.com Copyright © Hugin AS 2008. All rights reserved.
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