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news.CuraGen Corporation and TopoTarget have initiated patient dosing in a phase II clinical trial evaluating the activity of PXD101, a small molecule histone deacetylase inhibitor, for the treatment of a type of cancer called mesothelioma.
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Mesothelioma is a type of cancer arising from the cells, known as mesothelium, with the majority of cancers beginning in the chest cavity. The incidence of mesothelioma increases with age and is rarely diagnosed in patients under 55 years old. Exposure to asbestos is believed to be the main cause of the disease.
This trial is being sponsored by the National Cancer Institute (NCI) under an agreement with CuraGen for the clinical development of the compound. Patients with unresectable malignant pleural mesothelioma, who have failed one prior line of chemotherapy, will be enrolled and receive PXD101 by intravenous infusion every three weeks.
The primary endpoint for the study is response rate, with secondary endpoints evaluating safety and measuring both the time to treatment failure and survival. A total of approximately 37 patients are expected to be enrolled into this study at multiple sites across the US.
“Given the ability of HDAC inhibitors to down-regulate genes such as BCL-XL and VEGF and up-regulate cell-cycle regulating genes, including p21, we are excited to begin evaluating PXD101 as a potential treatment for this type of cancer,” said Dr Suresh Ramalingam, assistant professor of medicine at the University of Pittsburgh, and lead investigator in the study.
There are currently no proven treatments for mesothelioma beyond first-line chemotherapy.