DGAP-News

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

with other drugs. This resensitisation process can suppress or reverse drug
tolerance mechanisms that tumour cells often develop against other cancer
drugs and are catalysed by HDAC enzymes. Accordingly, supplementary
treatment with an HDAC inhibitor such as resminostat can thus restore - or
significantly improve - the efficacy of an initial cancer therapy. This
mechanism of action, i.e. tolerance breakdown via resensitisation through
HDAC inhibition, has previously been described in research1. The phase II
SHELTER trial is the first clinical study where this mechanism has been
investigated for the especially difficult to treat gastrointestinal
indication of advanced liver cancer (HCC) and documented for the
application of resminostat in combination with sorafenib, a tyrosine-kinase
inhibitor (TKI).

The principle of tumour cell resensitisation is highly relevant for
clinical practice, since the supplementary administration of resminostat
permits the continued treatment of patients with a cancer drug to which
patient response is no longer adequate. This can delay or avoid a change to
different cancer drugs - a procedure that is time-consuming and potentially
incriminating for the patient.

1 See Sharma et al., A chromatin-mediated reversible drug-tolerant state in
cancer cell subpopulations, Cell 2010;141(1):69-80.

Ends

Conference Call and Webcast

4SC will host a conference call and webcast on 19 January 2012 at 3pm CET
(9am EST) to inform about the data of the SHELTER study. Access to the
presentation slides can be obtained at:
http://4sc190112-live.cyber-presentation.de. Participants can access the
conference (conference ID: 4507526) under the following telephone numbers:

0800 10 12 072 (Germany)
0800 358 0886 (UK)
[phone] (USA)
[phone] (other countries)

Details of the Presentation:

Presentation No / Abstract No: C26 / 262
Title: Investigation of the HDAC inhibitor resminostat in patients with
sorafenib-resistant hepatocellular carcinoma (HCC): Clinical data from the
phase I/II SHELTER study
Session date, time and location: Friday, 20 January 2012, 11.45 am
Californian time (PST), General Poster Session B: Cancers of the Pancreas,
Small Bowel, and Hepatobiliary Tract, Moscone West Building, 2012
Gastrointestinal Cancer Symposium, San Francisco, California
Presenters: M. Bitzer, M. Horger, T. Ganten, J. Siveke, M.A. Woerns, M.M.
Dollinger, V. Zagonel, U. Cillo, G. Gerken, M.E. Scheulen, H. Wege, E.
Giannini, V. Montesarchio, F. Trevisani, A. Mais, R. Jankowsky, B. Hauns,