DGAP-Adhoc

4SC AG: 4SC provides headline results from Yakult Honsha's Phase II trial of resminostat in combination with sorafenib as first line therapy in liver cancer

4SC AG / Key word(s): Study results

27.05.2016 15:44

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4SC provides headline results from Yakult Honsha's Phase II trial of
resminostat in combination with sorafenib as first line therapy in liver
cancer

Planegg-Martinsried, Germany, 27 May 2016 - 4SC AG (4SC, FSE Prime
Standard: VSC) today announced that its Japanese partner Yakult Honsha Co.,
Ltd. (Yakult Honsha) has completed the randomized Phase II part of a
clinical Phase I/II study which evaluates 4SC's epigenetic cancer compound
resminostat in combination with the cancer drug sorafenib as a potential
novel first-line therapy of Asian patients in Japan and South Korea with
advanced liver cancer (hepatocellular cancer, HCC).

In April 2011, 4SC has granted an exclusive license to Yakult Honsha, the
Japanese market leader in gastro-intestinal cancer therapeutics, for the
development and commercialization of resminostat in Japan. After
successfully completing a Phase I safety study with resminostat in Japanese
patients with advanced solid tumors in May 2014, Yakult Honsha initiated
the Phase I/II study in patients with HCC, a cancer with high medical need
and very limited therapeutic options, which has a particularly high
incidence in Japan.

In the Phase II part in 170 Asian patients with advanced HCC, resminostat
in combination with sorafenib as first-line therapy in HCC did not meet the
primary endpoint of statistically significant prolonged time to disease
progression (TTP) compared to sorafenib monotherapy. Based on the result of
the Phase II part, Yakult Honsha will not conduct a pivotal study of
resminostat/sorafenib combination as first-line treatment of HCC in all-
comer patients.

However, patients with high expression levels of the ZFP64 biomarker at
baseline seem to have longer TTP in the sorafenib/resminostat combination
therapy when compared with sorafenib monotherapy.

Yakult Honsha is now analyzing the results in more detail. Other ongoing as
well as planned clinical trials, and in particular 4SC's anticipated Phase
II CTCL trial in the EU, will not be affected.


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Information and Explanation of the Issuer to this News:

About Resminostat

Resminostat is an HDAC (histone deacetylase) inhibitor administered in
tablet form with an innovative epigenetic mechanism of action. The compound
has already been clinically tested for treating Hodgkin's lymphoma as well