DGAP-News

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 - Seite 2

Yakult is currently investigating resminostat in two Phase I/II studies in
Asia, in liver cancer (hepatocellular carcinoma, HCC) and non-small-cell
lung cancer (NSCLC). HCC, a cancer with a high medical need and very
limited therapeutic options, has a particularly high incidence in Japan.
HCC is also the key indication of 4SC's planned clinical development
programme for resminostat in the Western world.

Enno Spillner, Chief Executive Officer of 4SC, said: "We are very pleased
that our partner Yakult Honsha has completed the Phase I part of study
confirming the clean safety profile of the resminostat/sorafenib
combination for the first time also in Asian HCC patients. We are delighted
about the great enthusiasm and energy of our Japanese partner in the
development of resminostat and we look forward to the Phase II part of the
study which will compare under randomised conditions the
resminostat/sorafenib combination to sorafenib alone, the current standard
of care for first-line treatment of HCC. In parallel, we will continue to
drive forward the preparation of our own clinical development plans with
resminostat in first-line HCC in the Western world."

Ends

About Resminostat

Resminostat (4SC-201), 4SC's lead oncology compound, is an oral
histone-deacetylase (HDAC) inhibitor with an innovative epigenetic
mechanism of action that potentially enables the compound to be deployed as
a novel, targeted tumour therapy for a broad spectrum of oncological
indications, in particular in combination with other cancer drugs.

Like other epigenetic therapies, resminostat has been shown to modify
transcription of genes in cancer cells and, thereby, to reprogram the
phenotypes of such cancer cells. Resminostat is therefore assumed to be
able to halt tumour progression and induce tumour regression. Furthermore,
due to its epigenetic mode of action resminostat is supposed to develop
additional synergetic effects when combined with classical cancer therapies
and thus also fight the development of tumour cell resistance. For example,
in preclinical trials, resminostat has shown that it effectively inhibits
epithelial-mesenchymal transition (EMT). EMT, which may be promoted through
the administration of certain conventional cancer therapies, leads to the
formation of particularly aggressive tumour cells, which ultimately may
result in greater proliferation of cancer cells in patients and the
patients' death. On the whole, a reinforcing positive therapeutic effect is
expected to be achieved through well-tolerated parallel administration of a