Epigenomics’ methylated SHOX2 Biomarker shows promising results
Methylated SHOX2 allows rapid and sensitive determination of tumor response and therapy monitoring in plasma of lung cancer patients
Epigenomics AG 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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