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Press Release: 4SC reports positive topline data from clinical Phase I trial with 4SC-205 in cancer patients using novel continuous dosing scheme

DGAP-News: 4SC AG / Key word(s): Study results/Miscellaneous
Press Release: 4SC reports positive topline data from clinical Phase I
trial with 4SC-205 in cancer patients using novel continuous dosing
scheme

09.12.2014 / 07:30

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Press Release

4SC reports positive topline data from clinical Phase I trial with 4SC-205
in cancer patients using novel continuous dosing scheme

- 4SC-205 is the only oral inhibitor of the Eg5 kinesin protein in
clinical development worldwide. Eg5 plays a crucial role in cell
division and tumour growth.

- Following positive data in 46 tumour patients using the conventional
dosing regimen, 4SC-205 has now been evaluated - as first compound of
its class - in a continuous ("metronomic") dosing scheme in 13 cancer
patients in a study amendment.

- Good results for safety and pharmacokinetics confirmed in the new
dosing scheme.

- Continuous treatment dose of 20 mg daily shows encouraging signs of
clinical efficacy and is recommended for potential Phase II
development.

Planegg-Martinsried, Germany, 9 December 2014 - 4SC AG (Frankfurt, Prime
Standard: VSC), a discovery and development company of targeted small
molecule drugs for cancer and autoimmune diseases, today announces positive
topline data from the clinical Phase I AEGIS trial with the anti-cancer
compound 4SC-205 in cancer patients. 4SC-205 inhibits specifically the
human kinesin spindle protein Eg5 which has been shown to play a crucial
role in cell division and, therefore, in tumour growth. To 4SC's knowledge,
4SC-205 is the only orally available Eg5 inhibitor in clinical development
worldwide.

Conducted at two trial centres in Germany, the open-label AEGIS
dose-finding study for the first time investigated the innovative 4SC-205
compound in 59 patients with advanced solid tumours. This involved the
testing of two separate dosing schemes. As previously reported, the first
part of the study, treating 46 patients with 4SC-205 in a conventional
dosing scheme (i.e. with single, larger doses and longer breaks between
treatment days), had delivered promising initial results for
pharmacokinetics, the tolerability profile and biomarkers.

The second part of the study has been completed now. In this study
amendment, 4SC-205 was evaluated in 13 patients with advanced solid tumours
using a "metronomic", or continuous, dosing scheme. In this regimen,
patients received the compound, in smaller single doses, daily and
continuously (= no breaks between treatment days). This regimen aims to