Prof. Dr. Michael Bitzer, the coordinating investigator from the University Hospital T bingen, Germany, commented, 'Advanced HCC is an aggressive form of cancer in which classical chemotherapy approaches fail, despite huge scientific efforts over decades. Only the recent approval of a targeted therapy sorafenib, the only approved therapy for the systemic treatment for advanced HCC, has offered an innovative approach to treat these patients. However, there is an unmet medical need for new therapeutic approaches for patients that do not tolerate, or have disease progression whilst under sorafenib treatment. Notably, this need is in the second line setting where there is currently no other approved treatment option. Based on preclinical and Phase I data generated by 4SC-201 (resminostat), we are hopeful that this HDAC inhibitor may offer considerable clinical benefit to HCC patients that are progressive under treatment with the only currently approved therapy.'

Dr Bernd Hentsch, Chief Development Officer at 4SC commented, '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.'

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