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news.CuraGen Corporation and TopoTarget have initiated patient dosing in a phase I/II clinical trial evaluating the safety and potential efficacy of PXD101, a small molecule histone deacetylase inhibitor, for the treatment of inoperable liver cancer.
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The trial is being sponsored by the National Cancer Institute (NCI) under a clinical trials agreement with CuraGen for PXD101.
The phase I portion of the study aims to establish the maximum tolerated dose, pharmacokinetics, and safety profile of PXD101 for patients with inoperable hepatocellular cancer. Approximately 15 patients will be enrolled in the dose escalation portion of the study and receive PXD101 in continuous three week cycles until disease progression.
Following determination of the maximum tolerated dose, the phase II portion of the trial will be initiated and enroll up to 29 additional patients to assess the safety and potential efficacy of PXD101.
“Hepatocellular carcinoma, also known as liver cancer, is an aggressive form of cancer that has limited treatment options for those patients who have inoperable disease. Preclinical research suggests that HDAC inhibitors, such as PXD101, have activity against hepatocellular carcinoma cell lines, potentially restoring normal gene expression and causing cancer cell death,” stated Dr Winnie Yeo, principal investigator, Department of Clinical Oncology, Chinese University of Hong Kong.