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 3

traditional cancer therapy and an epigenetic compound such as resminostat.

Resminostat - by 4SC and its Japanese partner Yakult - has been
investigated in a broad clinical campaign comprising liver cancer
(hepatocellular carcinoma, HCC), Hodgkin's Lymphoma (HL), colorectal cancer
(CRC), and non-small-cell lung cancer (NSCLC). In the Phase II SAPHIRE
trial in patients with advanced Hodgkin's Lymphoma (HL), resminostat
monotherapy has demonstrated anti-tumour activity, with an overall response
rate of 34% and a clinical benefit in 54% of the patients in a heavily
pre-treated patient population together with very good safety and
tolerability. In the Phase IIa SHELTER study resminostat has been evaluated
as monotherapy and in combination with sorafenib as a second-line treatment
in advanced HCC after proven radiological disease progression under
first-line sorafenib therapy. Patients receiving the resminostat/sorafenib
combination therapy showed a median overall survival of 8.1 months. The
resminostat/sorafenib combination therapy had shown a progression-free
survival rate (PFSR) after 12 weeks of 70.0% and a median PFS of 5.4
months. Notably, in both tumour indications, HCC and HL, gene expression
levels of the new biomarker ZFP64 measured prior to study treatment start
in blood cells of patients, were identified to be potentially indicative of
survival outcome upon treatment with resminostat. Hereby, the set of
patients with a high level of ZFP64 gene expression at baseline showed a
statistically significant increase of median overall survival compared with
patients with low ZFP64 expression levels. Resminostat was further studied
in a Phase I dose escalation approach in advanced colorectal cancer (CRC)
patients evaluating resminostat in combination with the standard
chemotherapeutic FOLFIRI regimen. Positive results for safety and
tolerability as well as promising signs of clinical activity of this
combination were published at the 2013 ASCO conference.

4SC is currently in preparation of the next step to develop resminostat
towards market approval in first-line HCC, a randomised-controlled,
double-blind Phase II study evaluating the resminostat sorafenib
combination compared to the current treatment standard sorafenib, as a
first line treatment of advanced HCC.

About the Resminostat Partnering Deal with Yakult Honsha for Japan

4SC granted an exclusive license to Yakult Honsha for the development and
commercialization of resminostat in Japan in April 2011. 4SC has received
an upfront payment from Yakult Honsha of EUR6 million and is eligible for