4SC Reports First Patient Dosing In Phase II Trial With 4SC-201

4SC has reported the dosing of the first patient in its phase II trial with 4SC-201 (resminostat), a pan-histone deacetylase (HDAC) inhibitor, as a new potential treatment option for patients with advanced hepatocellular carcinoma (HCC).

The proof-of-concept (POC) study will evaluate 4SC-201 as a second line therapy in this indication, for which only a single first line therapy drug is currently approved.

The ‘Shelter’ study is entitled ‘A proof-of-concept phase II study to evaluate efficacy, safety and pharmacokinetics of 4SC-201 and of the treatment combination of sorafenib plus 4SC-201 in patients with hepatocellular carcinoma exhibiting progressive disease under sorafenib treatment. It will examine whether treatment with 4SC-201 alone or in combination with sorafenib, can induce progression free survival and tumour responses in HCC patients, who display progressive disease under treatment with sorafenib.

In preclinical studies 4SC-201 was shown to be potent in inhibiting the growth of different liver cancer cells, and also displayed synergistic activity on liver cancer cell growth when combined with sorafenib.

Bernd Hentsch, chief development officer at 4SC, said: ‘We are very excited about commencing this proof-of-concept study for 4SC-201 (resminostat) in HCC, the first tumour disease to test the clinical efficacy of our lead oncology candidate. We have selected this indication as we believe that 4SC-201, based on our Phase I data, has the potential to stop tumour progression. We will investigate tumour responses in patients receiving monotherapy treatment with 4SC-201, and also after combination treatment, in which we will be able to additionally determine whether 4SC-201-can induce a re-sensitisation to treatment with sorafenib. Our new therapy option 4SC-201 could potentially offer tumour regression or a stabilised disease state, with the aim of moving these patients towards disease control.