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DUBLIN, Calif., Jan. 2, 2013 (GLOBE NEWSWIRE) -- Astex Pharmaceuticals, Inc. (Nasdaq:ASTX), a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics, announced that it has initiated a Phase 2, 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. Part A would enroll 15 patients in Stage 1 who will be evaluated for safety, disease control, and for methylation status of certain tumor suppressor genes known to be involved in HCC. If Part A is successful, Part B will enroll 31 additional patients in Stage 2. The primary endpoint of the study is disease control rate (DCR) at 16 weeks, defined as percentage of patients who achieve a best clinical response of complete or partial response, or stable disease at that time. Secondary endpoints of the study include the incidence and severity of adverse events, global DNA methylation levels, methylation status of selected tumor suppressor genes in tumor tissue, progression-free survival and overall survival.