Epigenomics AG Successfully Completes First Step towards Lung Cancer Screening Test Development

Many novel candidate DNA methylation biomarkers discovered - Candidate biomarkers broadly applicable to major subtypes of lung cancer - Clinical validation studies in blood to begin in 2007

Thursday, 05.10.2006, Berlin, Germany and Seattle, WA, USA, Epigenomics AG, (Frankfurt, Prime Standard: ECX), a molecular diagnostics company developing tests based on DNA methylation, today announced the successful identification of novel candidate biomarkers in lung cancer. This marks the completion of the first step in Epigenomics’ screening test R&D program for this fatal disease.

The program aims at developing a blood-based test for the reliable and convenient early detection of lung cancer. Such screening tests represent an urgent medical need, as the early and reliable detection of lung cancer offers better treatment options for patients.

By applying its proprietary discovery technology DMH, Epigenomics identified a large number of genes showing higher levels of DNA methylation in lung cancer compared to healthy lung tissue and other healthy and cancerous controls. The results were statistically significant. Importantly, a considerable number of these candidate DNA methylation biomarkers detected both major types of lung cancer, small cell lung cancer (SCLC) as well as non-small cell lung cancer (NSCLC). With this study, Epigenomics significantly added to its already broad intellectual property position in the field of lung cancer diagnosis. The majority of the identified candidate biomarkers were previously not described in the scientific literature.

Epigenomics now expects to confirm the most promising candidate biomarkers on a larger collection of lung cancer and control samples. First clinical validation studies using sensitive assays that detect the DNA methylation markers in blood are planned to begin in 2007. Epigenomics anticipates making the lung cancer program available for partnering or licensing at a later stage in development.

“Following the successful DNA methylation biomarker discovery in colon, prostate and breast cancer indications it is very encouraging to find promising candidate biomarkers also in lung cancer. These candidate biomarkers cover all major types of lung cancer”, said Christian Piepenbrock, COO of Epigenomics. “Such ‘pan-lung’ cancer biomarkers should allow us to develop a screening marker panel with high performance in detecting this fatal disease.”


Lung Cancer Screening
With over 381.500 cases of lung cancer in 2004 and a 5-year survival rate of about 15 percent, lung cancer is the leading cause of cancer deaths, accounting for about 20 percent of all cancer deaths in the EU alone. As in other cancers, the advanced disease cannot be treated effectively. Currently the most promising approach to improve outcome of lung cancer is to start treatment at an early stage. Because symptoms usually occur late in the course of the disease, mass screening focusing on early detection in individuals without symptoms is a prerequisite to achieve this goal.
Non- or minimally-invasive screening tests for lung cancer with high sensitivity and specificity that can be applied to large populations in a convenient, safe, and cost-effective way are urgently needed. With a combined market size approaching 200 million men and women aged 55 and older in US, Europe, and Japan, this is a highly attractive product opportunity in the diagnostics arena.

DNA Methylation
Methylation is a natural epigenetic process that occurs when a methyl group binds to one of DNA’s four bases, cytosine. Methylation is responsible for controlling the activity of genes by turning them off when not needed. Measuring the differences in the methylation patterns between healthy and diseased tissue can be used to detect a change in gene activity that could trigger diseases such as cancer. Epigenomics has developed an industrial process that is able to read and interpret these methylation patterns and uses them for developing molecular diagnostic tests.

About DMH
Differential Methylation Hybridization (DMH) is the most recent addition to Epigenomics’ proprietary DNA methylation technology portfolio. With Epigenomics’ DMH microarrays more than 50,000 human genomic fragments can be profiled for their methylation status in a single experiment. DMH is robust and delivers highly reproducible results. This makes DMH a fast and cost-effective tool to discover novel DNA methylation markers for diagnostic applications.

About Epigenomics AG
Epigenomics is a molecular diagnostic company with a focus on the development of novel products for cancer. Using DNA methylation markers, Epigenomics’ tests can potentially diagnose disease at an early stage and help guide physicians to select an appropriate therapy. Epigenomics collaborates with Roche Diagnostics on the development of several diagnostic products for the early detection of colon, prostate and breast cancer. Epigenomics also works with Qiagen (pre-analytics) and Affymetrix (diagnostic platform) as strategic partners for its molecular pathology products. The company has its headquarters in Berlin, Germany, and a wholly owned subsidiary in Seattle, USA. For more information, please visit Epigenomics’ website at www.epigenomics.com.

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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.