Astex Pharmaceuticals Initiates SGI-110 Phase 2 Trial in Advanced Hepatocellular Carcinoma Patients

Astex Pharmaceuticals

open-label, single-arm, non-randomized clinical trial, evaluating SGI-110 in the treatment of advanced hepatocellular carcinoma (HCC) patients who failed prior treatment with Nexavar (sorafenib). Advanced Hepatocellular Carcinoma (HCC) is a disease with a very high unmet medical need and patients who do not respond to the frontline standard of care, sorafenib, have few therapeutic options. The Phase 2 study is based on preclinical work showing that SGI-110 is effective in inducing global DNA and gene specific hypomethylation, thus enabling the re-expression of tumor suppressor genes in HCC cell lines (Jueliger, S. 2012, November. Poster presentation, EORTC-NCI-AACR, Dublin, Ireland). "There is a high unmet need for therapies for advanced HCC patients who have failed sorafenib treatment," said Mohammad Azab, MD, chief medical officer. "We are pleased to initiate this study which expands the investigational breadth of our development program for SGI-110 to include HCC in addition to the ongoing studies in myelodysplastic syndromes (MDS), acute myeloid leukemia (AML) and ovarian cancer." About the Study The study uses a Simon's 2-stage design.