Epigenomics Reaches 99.5 % Adherence for Epi proColon(R) in ADMIT Study

Epigenomics AG  / Key word(s): Study/Study results

08.05.2015 09:04

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Epigenomics Reaches 99.5 % Adherence for Epi proColon(R) in ADMIT Study

Berlin, Germany, May 8, 2015 - Epigenomics AG (Frankfurt Prime Standard:
ECX; ISIN: DE000A11QW50) announces results from the ADMIT trial (ADherence
to Minimally Invasive Testing - NCT02251782) for its non-invasive
blood-based test for colorectal cancer (CRC) screening, Epi proColon(R).
The study demonstrated a 99.5% rate of adherence to CRC screening using Epi
proColon(R), while the fecal immunochemical test (FIT) showed an adherence
rate of 88.1%. These numbers contrast to a baseline adherence to standard
of care CRC screening of less than 25%, as measured in a passive control
arm in which previously non-compliant patients were offered CRC screening
tests (FIT or colonoscopy) as part of their standard of care.

Adherence to Epi proColon(R) was significantly greater than adherence to
FIT, with an observed difference of 11.4% (p< 0.0001). 

The study was designed to determine whether the adherence to Epi
proColon(R) was significantly greater than to FIT plus a margin of 8.2%.
This margin was determined before the study based on a projected FIT
adherence rate. While adherence to Epi proColon(R) ultimately was higher
than the FIT adherence plus 8.2%, the comparison fell just short of
statistical significance (p=0.059). However, given the difference in the
observed FIT adherence rate in the study from the projected one,
demonstrating an adherence to Epi proColon(R) equaling the FIT adherence
rate plus a margin of 3.2% would have been sufficient to prove superiority.
In this scenario, the observed difference in adherence (11.4%) met
statistical significance (p< 0.0001).

Seeing adherence with Epi proColon approaching 100% clearly confirms
Epigenomics' assumption that blood-based CRC screening has the potential to
significantly lower the barrier for patients that have been historically
non-compliant to participate in CRC screening programs. The Company is
convinced that the study results support its pre-market approval (PMA)
application for Epi proColon(R) and plans to submit the data and further
discuss the study results with the U.S. Food and Drug Administration (FDA)
over the next few weeks.

The ADMIT trial was requested by the FDA in the context of Epigenomics' PMA
application for Epi proColon(R).

The study was originally designed to investigate CRC screening
participation for average risk, screening eligible study subjects that were
historically non-compliant to offered guideline-recommended screening
methods (colonoscopy or FIT testing) and included 413 eligible subjects
identified by Epigenomics' clinical trial partners, Kaiser Permanente and
Geisinger Health Systems. Study subjects were randomized to either a FIT
test kit for home use or a blood draw for the Epi proColon(R) test. Rates
of adherence were compared between those that accepted and completed the
blood test and those that accepted and completed the FIT test.

An observational secondary objective of the study aims to demonstrate the
number of patients who completed colonoscopy after positive test results
with Epi proColon(R) or FIT. This data will be reported to the FDA once the
study is formally completed within the next few weeks, i.e. up to six weeks
after the last positive test result of a study subject was obtained.


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Information and Explaination of the Issuer to this News:

Further Information

For further information please refer to 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 at 3pm CET/9 am ET
today, Friday 8th May 2015.

The dial-in numbers for the conference call are:
Dial-in number (within Germany): +49 69 247 501 895
Dial-in number (within the UK): +44 203 367 92 16
Dial-in number (within the U.S.): +1 408 9169 838

Participants are kindly requested to dial in 10 minutes prior to the start
of the call.

An audio replay of the conference call will be provided on Epigenomics'
website subsequently: https://www.epigenomics.com/en/news-investors.html

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.

Contact:
Epigenomics AG    
Antje Zeise CIRO
Manager IR | PR 
Epigenomics AG 
Phone: +49 (0) 30 24345 386 
ir@epigenomics.com
www.epigenomics.com

08.05.2015 The DGAP Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de

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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:       Regulated Market in Frankfurt (Prime Standard); Regulated
              Unofficial Market in Berlin, Dusseldorf, Munich, Stuttgart
 
End of Announcement                             DGAP News-Service
 
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