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news.CuraGen and TopoTarget have initiated patient dosing in a Phase II open-label, multi-center clinical trial evaluating the efficacy and safety of intravenous belinostat, a small molecule histone deacetylase inhibitor, for the treatment of patients with previously-treated thymoma and thymic carcinoma.
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This trial is being sponsored by the National Cancer Institute (NCI) under a clinical trials agreement with CuraGen for belinostat. The primary objective of the study is to determine the objective response rate by RECIST (response evaluation criteria in solid tumors) criteria. Secondary endpoints include evaluation of the time to response, duration of response, progression-free and overall survival. The pharmacodynamic activity of belinostat will also be evaluated by assessment of protein expression, changes in p21 and protein hyperacetylation, and identification of chromosomal gains or losses.
Timothy Shannon, President and CEO of CuraGen, said: “Several key targets of histone deacetylase (HDAC) inhibitor inhibition, including modulation of T cells, induction of the cyclin-dependent kinase inhibitor p21, and the inhibition of angiogenesis are involved in the pathogenesis and growth of thymic neoplasms. Belinostat was previously shown to have activity in treating a patient with thymoma, and we are therefore very interested in learning more about the potential activity of belinostat from this NCI-sponsored trial.”