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Epigenomics AG: Epigenomics Announces Completion of Enrollment in Epi proColon(R) ADMIT Trial

DGAP-News: Epigenomics AG / Key word(s): Study
Epigenomics AG: Epigenomics Announces Completion of Enrollment in Epi
proColon(R) ADMIT Trial

25.03.2015 / 07:30

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Press release

Epigenomics Announces Completion of Enrollment in Epi proColon(R) ADMIT
Trial

Berlin (Germany) and Germantown, MD (U.S.A.), March 25, 2015 - Epigenomics
AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American
cancer molecular diagnostics company, today announced the completion of
subject enrollment into its ADMIT trial (ADherence to Minimally Invasive
Testing - NCT02251782) for its non-invasive blood-based test for colorectal
cancer (CRC) screening, Epi proColon(R). The Company expects to announce
results from this study during the second quarter of 2015.

Epigenomics has successfully completed enrollment in the ADMIT clinical
trial this week. Study subjects were identified as historically
non-compliant to CRC screening according to current screening guidelines by
its partners, Kaiser Permanente and Geisinger Health Systems, who actively
manage CRC screening programs in the U.S.A. Subjects were invited to a
clinic visit and once enrolled into the trial, were randomized to either
the FIT test to take home to complete and send back within six weeks, or to
a blood draw for the Epi proColon(R) test, to be completed in the same time
frame.

The trial was requested by the US Food and Drug Administration (FDA) in the
context of Epigenomics' pre-market approval (PMA) application for Epi
proColon(R). It was designed to compare adherence to CRC screening in
subjects offered blood-based testing with Epi proColon(R) to stool-based
testing with a fecal immunochemical test (FIT), a guideline recommended
method. The primary endpoint is a statistically significant increase in
adherence to testing by subjects offered the Epi proColon(R) test compared
to subjects given the FIT test. The study's secondary objectives include a
measurement of compliance to colonoscopy in subjects with positive result
for either test.

Trial results will be submitted to the FDA following data analysis after
completion of the six week response window.

"We are encouraged and excited that we have reached our goal of achieving
this important milestone", stated Dr. Thomas Taapken, CEO/CFO of
Epigenomics. "We thank our partners Kaiser Permanente and Geisinger Health
System for their strong support in the conduct of this trial and, more than