Epigenomics Successfully Completes Clinical Study in Lung Cancer
Diagnosis
Biomarker panel opens up additional application areas based on
excellent bronchial lavage test results
Berlin, Germany, and Seattle, WA, USA, June 9, 2008 - Epigenomics AG
(Frankfurt Prime Standard: ECX), a molecular diagnostics company
focusing on the development and commercialization of products for
cancer based on DNA methylation, today announced that it successfully
completed a clinical study in its lung cancer program. The study was
run in close collaboration with Prof. Dr. Christian Witt and Dr.
Bernd Schmidt at the Charité - Universitätsmedizin Berlin, Germany.
The clinical study of 84 patient samples demonstrated that a panel of
two proprietary biomarkers detected 79% of lung cancers in bronchial
lavage specimens at specificity of 95%, i.e. only two false positives
results were obtained in 45 patients with benign lung diseases.
Bronchial lavage specimens are routinely taken during bronchoscopy
that is performed to diagnose lung cancer. In current clinical
routine, the bronchial lavage fluid is analyzed by a pathologist to
identify tumor cells. However, this microscopic analysis often cannot
either confirm or exclude lung cancer. A molecular diagnostic test
that sensitively and objectively detects the presence of tumor cells
in this specimen could potentially improve clinical decision making
for patients with suspected lung cancer.
"Bronchial lavage is a bronchioscopic standard procedure that is used
in lung cancer diagnosis when the tumor is not visible in the larger
airways. Yet, the detection of tumor cells not always works in the
lavage fluid. Molecular markers with the performance demonstrated in
our study could be of substantial benefit in this situation", says
Prof. Dr. Christian Witt, Head of the Department of Pneumology at the
Charité, Berlin.
The set of biomarkers comes out of Epigenomics' biomarker discovery
program using its proprietary DMH (differential methylation
hybridization) technology and has been extensively validated in tumor
tissue specimens before being tested on bronchial lavage. The assay
procedure used in this study relies on readily available solutions
for sample preparation including the EpiTect® kit for bisulfite
conversion marketed by Qiagen under license from Epigenomics.
"These data mark an important milestone in our lung cancer program",
commented Geert Nygaard, Chief Executive Officer of Epigenomics. "The
outstanding performance in high-risk patients opens up the
opportunity to develop or partner a product for additional indication
areas such as a radiology/CT reflex testing prior to lung biopsies. I
am very pleased with the execution of this clinical study that was
successfully completed ahead of schedule."
The detailed results of the study will be presented at the
International Lung Cancer Conference, Liverpool, UK, July, 9 - 12,
2008.
As next steps in its lung cancer program, Epigenomics expects to
further optimize the biomarker panel for application in bronchial
lavage specimens and perform an additional clinical study to confirm
the biomarker performance in an independent population. Based on the
outcome of this effort, the Company will evaluate the potential
development or partnering of a bronchial lavage diagnostic product.
The company also progressed the development of its lung cancer early
detection test and is in the final phase of a clinical study testing
blood plasma. This study aims at confirming the performance of a
biomarker panel for a potential lung cancer screening application in
a sizable sample set using an assay procedure that was optimized with
respect to costs, throughput and applicability in the clinical
routine. Data from this study is expected to be released in due
course.
About Lung Cancer
With about 386,300 new cases of lung cancer in Europe and over
174,000 new cases in the US in 2006, lung cancer is one of the most
common cancers in men and women accounting for about 20 percent of
all cancer deaths, more than any other cancer.
Despite the impressive progress of diagnostic imaging technologies,
the final cancer diagnosis still depends on the investigation of
tissues or cells by a pathologist.
Therefore in addition to Computed Tomography (CT), most individuals
suspected to have lung cancer undergo bronchoscopy, the main modality
used to further investigate these patients. Every year more than
200,000 bronchoscopies are performed in Germany alone, about 95% of
them due to a suspected tumor. Some tumors are visible in the central
airways and can be easily accessed for the examination by the
pathologist. If a lesion is beyond the scope of the endoscope,
bronchial lavage is routinely performed and the cells that are washed
out with the lavage fluid are sent for cytological examination, which
unfortunately has low sensitivity in diagnosing malignant lung
tumors. As a consequence, non-diagnostic results are not uncommon and
often lead to additional invasive procedures that are costly and pose
a considerable risk to the patients.
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.
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 24345 368 (phone)
achim.plum@epigenomics.com
