Berlin, Germany and Seattle, WA, U.S.A., March 18, 2009 -- Epigenomics AG (Frankfurt, Prime Standard: ECX) a cancer molecular diagnostics company developing tests based on DNA methylation has initiated the development of an in vitro diagnostic test for lung cancer. The decision was made after a successful retrospective clinical evaluation of bronchial lavage specimen from several hundred patients with suspected lung cancer demonstrated the ability of company’s lung cancer biomarkers to identify those with lung cancer.
Current guidelines do not recommend screening for lung cancer.
Individuals suspected to have bronchial carcinoma based on symptoms or accidental findings typically undergo chest X-ray, or CT scanning and bronchoscopy, i.e. the visual inspection of the bronchial airways with an endoscope, to establish the diagnosis. Often, the suspicious region in the lung cannot be assessed by endoscope directly and saline solution is injected (bronchial lavage) to recover cells for further cytological analysis by a pathologist. Unfortunately, the cytology report is frequently inconclusive and cannot confirm or exclude the presence of malignant disease. This poses an enormous challenge to the chest physician responsible for patient care as additional diagnostic procedures might be triggered including a second CT-scan after several months to check for growth of the nodules or an invasive needle or surgical lung biopsy. These additional diagnostic procedures result in either the loss of valuable time to treatment, or expose the patient to increased morbidity and mortality.
In the clinical evaluation conducted in collaboration with Prof. John Field (University of Liverpool), principal investigator of the Liverpool Lung Cancer Project funded by the Roy Castle Lung Cancer Foundation (Liverpool, UK), and Prof. Dr. Christian Witt and Dr. Bernd Schmidt from the Charité - Universitätsmedizin Berlin (Germany), confirmed that Epigenomics’ proprietary DNA methylation biomarkers reliably detected the majority of cancer cases from more than 400 patients with suspected lung cancer. Testing of previously collected bronchial lavage samples from patients suspected of having lung cancer, which were later found to have or not to have the disease, demonstrated virtually no false positive results even in cases with an inconclusive diagnosis by cytology.
“This clinical evaluation has confirmed the feasibility of utilizing Epigenomics’ biomarkers as a diagnostic tool for lung cancer. In particular when the current diagnostic work-up of samples obtained during bronchoscopy shows an inconclusive result, a test based on these biomarkers could simplify and speed up the diagnostic process by identifying patients with malignant lung disease without requiring additional invasive procedures. This assay may facilitate earlier diagnosis of lung cancer at a stage in which cure rates are higher”, concluded Prof. John Field, who will present the study data at the upcoming 100th Annual Meeting of the American Association for Cancer Research in Denver, Colorado, U.S.A. on April 21, 2009.
With about 386,300 new cases in Europe in 2006 and about 215,000 new cases in the U.S. in 2008, lung cancer is the most common cancer in men and women accounting for about 20 percent of all cancer deaths, more than any other cancer. About 200,000 bronchoscopies are performed in Germany alone every year, the vast majority of them for suspected lung cancer. Although most of these invasive procedures are performed in specialized centers, bronchoscopy in combination with the investigation of tissues or cells by a pathologist in many cases does not yield conclusive results and warrants further diagnostic work-up of the patients.
Epigenomics expects to provide the diagnostic test to selected centers for investigational use in Europe already this year. The market launch of a CE-marked diagnostic test kit by Epigenomics is scheduled for the first half of 2010. In addition to direct commercialization, Epigenomics may work with commercial partners in certain market segments and regions.
“In vitro diagnostic tests for lung cancer could address a huge unmet medical need in an area, that has seen very little innovation over the past few decades. With a reflex test following-up inconclusive bronchoscopies we can potentially bring great benefits to patients in the near future. Our future product will address an attractive and highly centralized niche market where we have established collaborations with leading lung cancer experts. This gives us the opportunity to commercialize the product ourselves, at least in some regions, and capture a larger part of the value”, explained Geert Nygaard, Chief Executive Officer of Epigenomics.
Conference Presentation Details
The poster with the Abstract No. LB-254 titled “SHOX2, a novel biomarker for the detection of lung cancer in bronchial fluid”, by John K Field, Volker Liebenberg, Dimo Dietrich, Triantafillos Liloglou, Martin Walshaw, Olaide Raji, Thomas Schlegel, Christoph Kneip, Juergen Distler, Reimo Tetzner, Christian Witt, Michael Fleischhacker and Bernd Schmidt will be presented in the poster session “Late-Breaking Research:
Clinical Research 2" in Hall B-F on April 21, 2009, 1:00 pm -- 5:00 pm, at the 100th Annual Meeting of the American Association for Cancer Research, April 18 -- 22, 2009, Colorado Convention Center, Denver, Colorado, U.S.A..
About Epigenomics
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 earlier stage or more accurately 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 urine, blood and bronchial lavage specimens. Epigenomics’ biomarker mSEPT9 for the early detection of colorectal cancer in a simple blood sample has repeatedly demonstrated excellent performance in multiple clinical studies with in total about 3,500 individuals tested. A large prospective clinical study
-- PRESEPT -- for evaluation of mSEPT9 in a screening population is currently under way (www.presept.net).
For development and global commercialization of in vitro diagnostic test products, Epigenomics pursues a non-exclusive partnering strategy.
Strategic diagnostics industry partners include Abbott Molecular, Philips, Sysmex Corporation and Quest Diagnostics for diagnostics test products, and QIAGEN N.V. for sample preparation solutions and research products.
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.
About The University of Liverpool
The University of Liverpool is a member of the Russell Group of leading research-intensive institutions in the UK. It attracts collaborative and contract research commissions from a wide range of national and international organizations valued at more than £93 million annually.
Further information at: http://liv.ac.uk/
About The Roy Castle Lung Cancer Foundation
The Roy Castle Lung Cancer Foundation (Registered Charity England & Wales 1046854 - Scotland SC037596) is the only charity in the UK wholly dedicated to defeating lung cancer -- the biggest cancer killer in the world. Its approach benefits current and future lung cancer sufferers alike:
• The foundation funds research programs to detect lung cancer at a very early stage, which will save lives and is vital to the development of a future therapy.
• The foundation offers patient support, advocacy and an information network providing information, guidance and support relevant to the needs of lung cancer patients and their families.
• The foundation facilitates support groups across the UK that help sufferers to come to terms with the disease and provide patient advocacy services.
• The foundation operates ‘Quit Smoking’ services for adults (Fag Ends).
• KATS (Kids Against Tobacco Smoke) educational program for children which encourages young people never to start smoking.
• ATYC (Anti Tobacco Youth Campaign) which gives young people a voice, knowledge and skills to campaign about smoking and other tobacco issues.
• The Roy Castle Lung Cancer Foundation runs fundraising events and charity shops, both of which help to generate much needed voluntary donations (public and corporate), on which it relies to continue its fight to defeat lung cancer.
If you would like to know more about how you can support the Roy Castle Lung Cancer Foundation, please contact +44 (0)151 254 7200 or visit www.roycastle.org for further information.
Epigenomics’ legal 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.
Products based on the biomarkers described are not available for sale in the United States. The analytical and performance characteristics of any product to be eventually sold in the U.S. based on this technology have not been established.
