TopoTarget/Curagen begins dosing in Ph II PXD101 trial

Copenhagen, Denmark-based TopoTarget AS and the USA's CuraGen have initiated patient dosing in a Phase II clinical trial evaluating the antitumor activity of intravenous PXD101, a small-molecule histone deacetylase inhibitor, for the treatment of ovarian cancer.

This Phase II open-label study is being sponsored by the National Cancer Institute under a Clinical Trials Agreement with CuraGen. Patients enrolled into the Phase II trial, which is an open-label study, will receive intravenous PXD101 daily for five days in three-week cycles until disease progression occurs. The primary endpoint is determination of objective disease response, as evaluated by the Response Evaluation Criteria in Solid Tumors criteria, while secondary endpoints include evaluation of safety and tolerability of PXD101, stable disease rates, duration of response, progression-free survival and median and overall survival. Up to 62 patients at sites across Canada and the USA will be enrolled into the study.