DGAP-Adhoc

4SC AG: 4SC´s cancer compound resminostat meets primary endpoint in Phase II trial in advanced liver cancer (HCC) ahead of schedule - Seite 2

considerably longer - well over a year - in individual cases. Accordingly,
the progression-free survival rate (PFSR) after 12 weeks is currently 66.6%
for the combination therapy group and 33.3% for the monotherapy group of
currently 9 evaluable patients. Furthermore, median progression-free
survival (PFS), which is defined as the period of time for which the
progression of the disease can be halted, is presently 4.6 months (140
days) for the combination therapy group and 1.4 months (42 days) for the
monotherapy group.

In general, resminostat has proven to be safe and well-tolerated. The most
frequent side-effects observed were of a gastrointestinal nature
(diarrhoea, nausea). In the combination arm, in the majority of cases the
side effects were attributed to the treatment with sorafenib. The majority
of serious adverse events (SAEs) were attributed to the patient´s
underlying disease; a consistent profile of SAEs which were causally
related to the study medication was not observed.

The data presented now were analysed before database closure and are based
on the analysis of the primary study endpoint ´progression-free survival at
12 weeks´ conducted by the local trial centres. Currently, five patients
who have not been evaluated after 12 weeks yet are undergoing study
treatment, while another five patients continue treatment optionally after
experiencing a clinical benefit through the halt of disease progression for
at least 12 weeks of study participation. Patients withdrawing from the
trial for other reasons than disease progression are qualified as ´drop
outs´ and therefore replaced. The final results of the SHELTER study, as
determined following database closure and encompassing all patients
enrolled as well as a final, centralised radiological report are expected
to be presented at an international scientific conference in the course of
2012.

Details of the efficacy data now presented based on the identification of
the primary study endpoint ´progression-free survival at 12 weeks´:

Combination therapy (Resminostat 600 mg, Sorafenib 400 mg)

Patients enrolled (´intention-to-treat´, ITT): 26
of which drop-outs*: 7
Currently evaluable patients after 12 weeks (EP)*: 15
of which with stable disease (SD), i.e. ´progression-free survival´ (PFS):
10
of which with progressive disease (PD): 5  
Progression-free survival rate after 12 weeks PFSR (=PFS/EP): 10/15= 66,6%

Monotherapy (Resminostat 600 mg)

Patients enrolled (´intention-to-treat´, ITT): 12
of which drop-outs*: 2
Currently evaluable patients after 12 weeks (EP)*: 9
of which with stable disease (SD), i.e. ´progression-free survival´ (PFS):