Epigenomics AG’ Methylated SHOX2 Biomarker Shows Promising Results For Therapy Monitoring Of Lung Cancer Patients
• Methylated SHOX2 allows rapid and sensitive determination of tumor response and therapy monitoring in plasma of lung cancer patients
• Multi-centric study with larger patient population planned for verification
• Further demonstrates commercial value of Epigenomics’ DNA methylation platform
Berlin, Germany and U.S.A., November 20, 2013 - Epigenomics AG (Frankfurt Prime Standard: ECX, OTC: EPGNY), the German-American cancer molecular diagnostics company, today announced the results from a clinical study conducted by Dr. rer. nat. M. Fleischhacker and PD Dr. med. B. Schmidt from the Department of Pulmonology of University Hospital (UKH) Halle/Saale
The study demonstrated methylated SHOX2 to be a sensitive and specific biomarker for therapy monitoring and early detection of tumor response in lung cancer patients. The blinded study was conducted between December 2012 and June 2013, whereby blood samples from a total of 32 advanced stage lung cancer patients were taken prior to and during therapy every seven to ten days for approximately three months. Re-staging after that period was confirmed by a local tumor board based on clinical and imaging (CT scan) results. Epigenomics’ proprietary biomarker mSHOX2 was detected using a modified Epi proLung® BL assay.
At re-staging, 14 out of the 32 patients with progressive disease showed no change or an increase in the amount of methylated SHOX2. 13 patients with treatment response showed a decrease of methylated SHOX2 under therapy. In the majority of patients this response to therapy was seen at the time of second blood draw. By the time of blood draw four, i.e. 4 weeks after start of therapy, a decrease of methylated SHOX2 was observed in all patients. Five patients, who had received a therapy before enrollment in the study, were negative for methylated SHOX2 from the very beginning. The results of this study were recently presented by Dr. M. Fleischhacker at the CNAPS VIII meeting in Baltimore.
“The results reported in this study demonstrate further potential of our proprietary SHOX2 DNA methylation biomarker. Cell-free mSHOX2 DNA isolated from plasma and bronchial lavage has already proven to be a sensitive and specific marker for the detection of lung cancer. It is exciting to see that the biomarker additionally enables rapid and sensitive determination of tumor response and therapy monitoring”, said Dr. Uwe Staub, COO of Epigenomics. “As of today there is no sensitive and standardized biomarker to indicate a patient’s response to therapy or the need to change a therapy due to tumor progression in lung cancer patients.”?? An additional multi-centric study with a larger patient population is planned to verify these exciting initial results.
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Antje Zeise, Manager IR | PR Epigenomics AG Kleine Praesidentenstrasse 1 10178 Berlin Tel +49 (0) 30 24345 386 ir@epigenomics.com www.epigenomics.com
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About Epigenomics
Epigenomics (www.epigenomics.com) is a molecular diagnostics company developing and commercializing a pipeline of proprietary products for cancer. The Company’s products enable doctors to diagnose cancer earlier and more accurately, leading to improved outcomes for patients. Epigenomics’ lead product, Epi proColon®, is a blood-based test for the early detection of colorectal cancer, which is currently marketed in Europe and is under regulatory review for the U.S.A. The Company’s technology and products have been validated through multiple partnerships with leading global diagnostic companies and testing laboratories. Epigenomics is an international company with operations in Europe and the U.S.A.
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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. The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on this technology is currently available for sale by Epigenomics in the United States or Canada. The analytical and clinical performance characteristics of any Epigenomics product based on this technology which may be sold at some future time in the U.S. have not been established.
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