Epigenomics AG Presents New Clinical Data on Colorectal Cancer Screening Markers

Wednesday, 05.07.2006, Berlin, Germany and Seattle, WA, USA, Epigenomics AG (Frankfurt, Prime Standard: ECX), a molecular diagnostics company developing tests based on DNA methylation, is presenting new clinical data on its colorectal cancer early detection marker in blood. The results indicate that, combined with a second proprietary marker, the test is also able to detect most polyps without many false positive results. Colon polyps are benign proliferations that can give rise to cancer. The risk is considerably high if they are greater than 1 cm in size. Their timely removal is therefore a major contribution to saving patients’ lives. Data were presented at the 8th World Congress on Gastrointestinal Cancer in Barcelona from June 28 to July 1.

The study was based on a total of 49 blood plasma samples from patients with colon polyps and 22 patients without polyps. Researchers studied two proprietary Epigenomics markers alone and in combination: Septin9, a marker which has already been presented by Epigenomics earlier this year and ALX4, a previously undisclosed marker identified by Epigenomics.

The combination of the two markers detected clinically relevant polyps with very high sensitivity. Detection rate for polyps larger than 1cm was 67% (12 out of 18 plasma samples from patients with polyps). Sensitivity for large dysplastic polyps (adenomas >1 cm) was 100% and for adenomas with intraepithelial neoplasia, i.e. a substantial likelihood of developing invasive cancer was 80%. The specificity of the combination as tested in asymptomatic patients over 50 years of age was 91%.

“The experiment shows that our development strategy to improve colorectal cancer screening by combining markers into panels clearly works,” said Christian Piepenbrock, COO of Epigenomics.

“This study demonstrates that we can find even earlier stages in cancer development,” said Catherine Lofton-Day, Ph.D., Vice-President Molecular Biology, Diagnostics. “Therefore, a test based on these markers has the potential to save even more lives.”

About DNA methylation
Methylation is a natural epigenetic process that occurs when a methyl group binds to one of DNA’s four bases, cytosine. The presence of methylation is responsible for controlling the activity of genes by turning them off, like a switch, when not needed. By measuring the differences in the methylation patterns between healthy and diseased tissue, a change in gene activity that could trigger diseases such as cancer is detected. Epigenomics has developed an industrial process that is able to read and interpret these methylation patterns.

About the DNA methylation markers
The Septin9 gene is encoding for a protein involved in cell division and is thought to play a role in the onset of cancer. The ALX4 gene encodes for a putative transcription factor, suggesting a role in gene regulation. The DNA methylation technology of Epigenomics is able to detect the methylated forms of these genes in blood samples taken from patients.

About Epigenomics
Epigenomics is a molecular diagnostic company with a focus on the development of novel products for cancer. By detecting and interpreting DNA methylation patterns, Epigenomics’ tests can potentially diagnose disease at an early stage and help guide physicians to select an appropriate therapy. The company has its headquarters in Berlin, Germany, and a wholly owned subsidiary in Seattle, USA. For more information, please visit our 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.

Contact Information

Christian Piepenbrock

COO

Epigenomics AG

Contact via E-mail