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Press Release: 4SC's partner Yakult Honsha completes Phase I part of clinical study with resminostat in Asian HCC patients and starts randomised Phase II part

DGAP-News: 4SC AG / Key word(s): Miscellaneous
Press Release: 4SC's partner Yakult Honsha completes Phase I part of
clinical study with resminostat in Asian HCC patients and starts
randomised Phase II part

23.09.2014 / 07:30

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Press Release

4SC's partner Yakult Honsha completes Phase I part of clinical study with
resminostat in Asian HCC patients and starts randomised Phase II part

- Phase I confirms safety and tolerability of resminostat/sorafenib
combination in the planned dose regimen in Asian HCC patients

- Phase II to compare efficacy of resminostat/sorafenib combination with
current HCC standard of care (sorafenib monotherapy) in up to 140 Asian
1st line HCC patients

Planegg-Martinsried, Germany, 23 September 2014 - 4SC AG (Frankfurt, Prime
Standard: VSC), a discovery and development company of targeted small
molecule drugs for cancer and autoimmune diseases, today announced that its
Japanese partner Yakult Honsha Co., Ltd. has successfully completed the
Phase I part and initiated the randomised 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 advanced Asian HCC patients.

In the dose escalation Phase I part in 9 Asian patients with advanced HCC,
the resminostat/sorafenib combination proved to be safe and well tolerated.
Based on the result of the Phase I part, the multi-centre randomised Phase
II part of the trial has been started. It will compare the efficacy of the
resminostat/sorafenib combination with the current HCC standard therapy of
sorafenib as a first-line treatment in up to 140 patients with advanced
HCC. The primary endpoint will be time-to-progression (TTP). Secondary
endpoints are, inter alia, overall survival (OS), progression-free survival
(PFS) and safety. The study will also evaluate the ZFP64 biomarker. All
patients enrolled have to be previously untreated with systemic
chemotherapy.

The development of resminostat in the Japanese market is of high strategic
importance to 4SC. 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 commercialisation of resminostat in
Japan. After successfully completing a Phase I safety study with
resminostat in Japanese patients with advanced solid tumours in May 2014,