Berlin (Germany) and Germantown, MD (U.S.A.) – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American cancer molecular diagnostics company, today provides a corporate update on major developments.
Epigenomics, in consultations with the U.S. Food and Drug Administration (FDA), has completed the design of the ADMIT (Adherence to Minimally Invasive Testing) study, which aims to demonstrate that Epi proColon® will increase participation in colorectal cancer (CRC) screening in patients being offered this convenient blood-based test as compared to those being offered a fecal immunochemical test (FIT). The study was requested as part of the FDA response letter on June 2, 2014 in relation to Epigenomics’ PMA submission for the Company’s CRC screening test. It will be conducted in average risk, screening eligible patients that have been historically non-compliant to CRC screening according to current guidelines. Once enrolled, patients will be randomized equally into two arms to be offered either the FIT stool test kit for home use or a blood draw for the Epi proColon® test. The rates of adherence between each arm will be measured and the primary objective of the study will be to show increased adherence for Epi proColon®. The study’s secondary endpoint is a measurement of compliance to colonoscopy in those patients with positive test results with Epi proColon® or FIT. For the identification of appropriate patients Epigenomics will be working with two major US health care systems, who actively manage CRC screening programs. Based on initial estimates, the Company expects the trial to be enrolled within a few months and costs for the study are projected to be less than EUR 1.0 million.
In parallel, Epigenomics is working closely with its partner BioChain towards the approval of Epi proColon® in China, where CRC is a rapidly growing problem also. Epigenomics has supported the data generation and technical documentation efforts of BioChain throughout the approval process, which was initiated in April of this year. Additionally, clinical data generated in China have confirmed the performance of the Epi proColon® test in the Chinese population. These data were included in the formal submission to the China Food and Drug Administration (CFDA). Based on the information provided and on the promising results of BioChain’s clinical trial announced in April 2014, the company expects an approval decision in the foreseeable future.
Lastly, Epigenomics expects that it will make use of available financing options before the end of the year. , Epigenomics is seeking to extend its cash reach to secure the necessary funds for the execution of important next steps and completion of the above mentioned milestones.
“We will keep the markets updated on future developments and announce major steps regarding progress in the ADMIT trial and our ongoing market applications in the US and China”, stated Thomas Taapken, CEO of Epigenomics. “After very busy summer months preparing for the ADMIT trial, we are now ready to embark on the final steps of the approval for Epi proColon® in the US and China. We remain optimistic about the prospects of the Company and thank our shareholders for their ongoing support.”
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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 by the FDA for the U.S.A. and the Chinese Food and Drug Administration for China. Additionally, the company markets its tissue assay for use in lung cancer diagnosis, Epi proLung®, in Europe. 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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