Epigenomics AG / Key word(s): Alliance 03.11.2014 / 10:34 Epigenomics’ strategic commercialization partner Polymedco reiterates its commitment to support Epi proColon(R) in the United States
Berlin (Germany) and Germantown, MD (USA), November 03, 2014 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American cancer molecular diagnostics company, today announced that Polymedco, Inc., a leading provider of colorectal cancer tests in North America, reiterates its commitment to support Epi proColon(R) in the United States. Epi proColon(R) is Epigenomics’ convenient blood-based test for colorectal cancer (CRC) screening, which is under review by the U.S. Food and Drug Administration (FDA) for U.S. market approval. Polymedco is continuing to diligently prepare for commercializing Epi proColon(R) once the product is approved and has started internal training measures and to establish customer and technical support. In addition, Polymedco strongly supports Epigenomics with continued logistics and personnel assistance in the upcoming ADMIT (Adherence to Minimally Invasive Testing) study, which aims to demonstrate that Epi proColon(R) will increase CRC participation in patients being offered this convenient blood-based test as compared to those being offered a fecal immunochemical test (FIT). This strong support of Epigenomics’ partner is further underpinned by the commitment of Polymedco’s President and CEO, Drew Cervasio, who with a significant personal investment has meanwhile increased his ownership of Epigenomics to approximately 180,000 shares. “As we work towards fulfilling the requirements outlined by the FDA, we are encouraged by the support and commitment displayed by Polymedco”, said Dr. Thomas Taapken, Chief Executive Officer of Epigenomics. “We are delighted with the strong signs of our strategic partners, Polymedco, and also BioChain in China, showing their belief in the future success of our product.” During the recent months, Epigenomics worked closely with the FDA and completed the design of the ADMIT study which is now being started in the U.S. To identify appropriate patients to be enrolled, Epigenomics is conducting the study with two major U.S. health care systems, who actively manage CRC screening programs. Site initiation for the trial is now ongoing. The ADMIT study 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(R) test. The rates of adherence in each arm will be measured and the primary objective of the study will be to show increased adherence for Epi proColon(R) compared to FIT testing. The study’s secondary endpoint is a measurement of compliance to colonoscopy in those patients with positive test results with Epi proColon(R) or FIT. The study was requested by the FDA in relation to the Company’s premarket approval (PMA) application for Epi proColon(R) in the U.S. – Ends – Contact Epigenomics AG Antje Zeise, Manager IR | PR Epigenomics, Inc. About Epigenomics About Polymedco Epigenomics legal disclaimer 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.
03.11.2014 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG. The issuer is solely responsible for the content of this announcement. The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. |
Language: | English | |
Company: | Epigenomics AG | |
Geneststraße 5 | ||
10829 Berlin | ||
Germany | ||
Phone: | +49 30 24345-0 | |
Fax: | +49 30 24345-555 | |
E-mail: | ir@epigenomics.com | |
Internet: | www.epigenomics.com | |
ISIN: | DE000A11QW50 | |
WKN: | A11QW5 | |
Listed: | Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr in Berlin, Düsseldorf, München, Stuttgart | |
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