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Epigenomics AG Provides Update on Regulatory Status and Information on Additional Clinical Study for Epi proColon(R) in the U.S.

DGAP-News: Epigenomics AG / Key word(s): Study
Epigenomics AG Provides Update on Regulatory Status and Information on
Additional Clinical Study for Epi proColon(R) in the U.S.

01.07.2014 / 15:15

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Press release

Epigenomics AG Provides Update on Regulatory Status and Information on
Additional Clinical Study for Epi proColon(R) in the U.S.

Berlin (Germany), Germantown, MD (U.S.A.), July 1, 2014 - Epigenomics AG
(Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American cancer
molecular diagnostics company, reports on the status of its Pre-Market
Approval (PMA) application with the U.S. Food and Drug Administration (FDA)
and provides information regarding the design and objectives of an
additional clinical study requested by the FDA for regulatory approval of
Epi proColon(R), the Company's blood-based colorectal cancer (CRC)
screening test in the U.S.

In a recently held meeting between the Company and the FDA, detailed
discussions were held to specify the details regarding the design of this
clinical study. Epigenomics proposed to conduct a study to demonstrate that
Epi proColon(R) will increase participation in CRC screening in patients
being offered the blood-based test as compared to those being offered a FIT
stool-based test. The trial is intended to be conducted in a population
that is non-compliant to CRC screening according to current screening
guidelines and may include patients actively managed by CRC screening
programs within healthcare systems. Discussions with several healthcare
organizations to participate in such a study are already underway. While a
decision on the final study plan has not yet been taken, an adaptive study
design could allow early completion of the study if statistical
significance is clearly met. Based on these initial assumptions Epigenomics
foresees that conducting the study can likely be done with a reasonable
number of patients that could be enrolled in a matter of a few months.
However, additional time will need to be allocated for study initiation and
logistics. Once the study has been completed, a PMA amendment with study
results will be filed within a reasonable period of time.

The study's secondary objectives will include a measurement of compliance
to colonoscopy in those patients with positive test results with Epi
proColon(R) or FIT. For this endpoint, the results will be descriptive and
will not be reported with statistical significance in the premarket