Resminostat: Additional Phase II data

4SC said a biomarker analysis of data from the open-label, German and Italian Phase II SHELTER trial in 45 patients with HCC refractory to Nexavar sorafenib showed that the level of expression of the zinc finger protein 64 (ZFP64) biomarker at baseline was significantly correlated with OS outcomes in HCC patients treated with resminostat (p=0.04). Specifically, second-line treatment with resminostat led to a median OS in patients with high ZFP64 expression levels at baseline that was double the median OS in patients with low ZFP64 expression levels at baseline. 4SC said the correlation between ZFP64 expression and OS was observed in patients treated with resminostat either as monotherapy or in combination with Nexavar. 4SC did not disclose the specific thresholds for high and low ZFP64 expression levels. Patients received once-daily 600 mg oral resminostat for 5 consecutive days followed by 9 treatment-free days in a 14-day cycle with or without continuous twice-daily oral Nexavar. Data were presented at the International Liver Cancer Association meeting in Washington D.C. 4SC said it plans to integrate the biomarker data into the design of a planned Phase II/III trial with resminostat as first-line treatment of advanced HCC. The company said it is in discussions with regulatory agencies and potential partners to prepare next steps for the program. ...