DGAP-News

4SC AG: Cancer compound resminostat meets primary endpoint in Phase II trial in advanced liver cancer ahead of schedule - Seite 2

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.

Ulrich Dauer, Chief Executive Officer of 4SC AG, said: ´The now presented
data of our SHELTER study validate impressively the growing applicability
of the new epigenetic mechanism of action offered by our lead anti-cancer
compound resminostat. Tumour cell resensitisation, which is mediated by
resminostat through the inhibition of HDAC enzymes, is highly relevant for
clinical practice, since the supplementary administration of resminostat
can permit the continued and effective treatment of patients with a cancer
drug to which patient response is no longer adequate. In particular for
patients suffering from advanced liver cancer and who urgently need new
treatment options it would be a tremendous success to reduce the risk of
disease progression. It is therefore very promising that in our study for
two-thirds of patients with advanced HCC, who no longer responded to
sorafenib - the only compound previously approved for this condition - the
supplementary administration of resminostat prevented the further disease
progression for at least 12 weeks and for much longer in individual cases.
Resminostat also showed promising activity as a monotherapy. In order to
confirm these encouraging and, as we are convinced, clinically highly
relevant data, we are now planning to conduct a pivotal clinical study
programme relevant for registration in this indication and we will
therefore intensify our talks on this topic with the regulatory agencies
and potential partners.´

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