DGAP-News

4SC AG: Cancer compound resminostat meets primary endpoint in Phase II trial in advanced liver cancer ahead of schedule - Seite 3

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), ´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), ´progression-free survival´(PFS): 3
of which with progressive disease (PD): 6  
Progression-free survival rate after 12 weeks PFSR(=PFS/EP): 3/9=33,3%

*Patients who withdrew from the study before their tumour status was
determined radiologically after 12 weeks - and for whom an evaluation of
tumour progression or stabilisation was therefore not possible - have not
been included in the evaluable patient population (EP). Of the nine
patients listed as drop-outs most left the study for personal reasons (i.e.
withdrawal of consent), all of them without an observed tumour progression.
Early withdrawal because of side effects was a rare occurrence and only
partly attributable to the study medication.

Increasing clinical relevance of epigenetically induced tumour cell
resensitisation

Resminostat, 4SC´s lead oncology compound, is an oral
pan-histone-deacetylase (HDAC) inhibitor with an innovative epigenetic
mechanism of action that enables this compound to be deployed as a novel,
targeted tumour therapy for a broad spectrum of oncological indications,
both as a monotherapy and in combination with other cancer drugs. By
causing structural changes to DNA, resminostat triggers a differentiation
in tumour cells, can induce programmed cell death in cancer cells
(apoptosis) and is able to halt tumour growth. Additionally, resminostat
induces what is known as tumour cell ´resensitisation´ to the treatment