EANS-Adhoc: Ad hoc Announcement Pursuant to § 15 WpHG (German Securities Trading
Act): Epigenomics AG Reports Non-Inferiority of Blood-based Epi proColon®
against Fecal Immunochemical Testing in Detection of Colorectal Cancer in a
Head-to-Head ...
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ad-hoc disclosure pursuant to section 15 of the WpHG transmitted by euro
adhoc with the aim of a Europe-wide distribution. The issuer is solely
responsible for the content of this announcement.
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other/New Products/other/New Products/molecular diagnostics
04.12.2012
Berlin, Germany, December 04, 2012 - Epigenomics AG (ISIN: DE000A1K0516)
announces top-line results from a head-to-head comparative study between its
blood-based colorectal cancer (CRC) detection test Epi proColon® and fecal
immunochemical testing (FIT) to demonstrate the non-inferiority of Epi proColon®
in detection of CRC.
In the reported trial, Epi proColon® detected 73 in a total of 103 evaluable
samples from patients with colorectal cancer, which represents a sensitivity of
71%. The FIT comparator used in the study, one of the most commonly used FIT
products in the US market, detected 66 out of 98 cancer cases for which stool
samples were provided, translating into a sensitivity of 67%. Based on
Epigenomics' analysis of the data, which was confirmed by an external party, the
Company met the critically important endpoint of non-inferiority with respect to
sensitivity of Epi proColon® to FIT. These results represent an important
milestone for Epigenomics and will be part of the final module of the Premarket
Approval (PMA) submission expected to be filed with the U.S. Food and Drug
Administration (FDA) before the end of this year.
The double blind study was performed at 70 clinical trial sites across the US
and comprised two arms. The first arm included a total of 103 asymptomatic,
average risk individuals without family history or previous incidences of CRC,
who were diagnosed and confirmed as having colorectal cancer during a screening
colonoscopy. Matched blood and stool samples from these patients were collected
at least 10 days after colonoscopy but before surgical intervention. The second
arm of the study included 198 individuals selected according to the same
criteria, but whose blood and stool samples were collected before colonoscopy.
This study arm included three cancer cases as well as advanced adenomas, polyps
and individuals with no evidence of disease. Based on all non-CRC samples from
the second arm, specificity for Epi proColon® was determined at 81% and for FIT
at 98%. These findings are in line both with previous studies on Epi proColon®
and published data for FIT. In summary, Epigenomics met the critically important
sensitivity endpoint, which provides the potential to discover more CRC
patients. The difference in specificity was anticipated and in the Company's
opinion is less vital, since patients will undergo a colonoscopy -the currently
recommended screening procedure- as a result of a positive test result. Testing
of all samples was performed strictly according to the instructions for use by
the respective manufacturers of both tests at an independent third party testing
laboratory in the US, which was blinded to the samples analyzed.
The company plans to submit detailed study results for presentation at a medical
meeting and for peer reviewed publications in the near future.
- End of Ad hoc -
Further Information
For further information please see the press release issued today by Epigenomics
AG at www.epigenomics.com
Conference call for press and analysts
Epigenomics' management will host a conference call and an audio webcast at 5pm
CET/11am EST, 4th December 2012.
The dial-in numbers for the conference call are:
Dial-in number (within Germany): + 49 69 247501899
Dial-in number (within the UK): + 44 203 1474861
Dial-in number (within the U.S.): + 1 212 4440297
Participants are kindly requested to dial in 10 minutes prior to the start of
the call.
A webcast of the conference call will be provided on Epigenomics' website
subsequently: http://www.epigenomics.com/en/news-investors.html
Contact Epigenomics AG
Antje Zeise CIRO
Manager IR | PR
Epigenomics AG
Phone: +49 (0) 30 24345 386
ir@epigenomics.comwww.epigenomics.com
Epigenomics' legal disclaimers. 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.
Further inquiry note:
Antje Zeise | CIRO
Manager IR/PR
Epigenomics AG
Tel: +49 30 24345 386
antje.zeise@epigenomics.com
end of announcement euro adhoc
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issuer: Epigenomics AG
Kleine Präsidentenstraße 1
D-10178 Berlin
phone: +49 30 24345-0
FAX: +49 30 24345-555
mail: ir@epigenomics.com
WWW: http://www.epigenomics.com
sector: Biotechnology
ISIN: DE000A1K0516
indexes: Prime All Share, Technology All Share
stockmarkets: free trade: Berlin, München, Hamburg, Düsseldorf, Stuttgart,
regulated dealing/prime standard: Frankfurt
language: English