CuraGen and TopoTarget have announced the initiation of patient dosing in a Phase II clinical trial evaluating the efficacy and safety of PXD101, a small molecule histone deacetylase (HDAC) inhibitor, for the treatment of cutaneous T-cell (CTCL), peripheral (PTCL) and other T-cell non-Hodgkin's lymphomas (NHL). Preliminary results from this open-label, multi-center study are expected by mid-2007.

The Phase II study aims to establish the efficacy and safety of PXD101 as a single-agent treatment for CTCL, PTCL, and other T-cell NHL. Patients with T-cell NHL will be enrolled into one of two parallel arms depending on disease classification. Approximately 25 patients will initially be enrolled into the study with up to an additional 70 patients enrolled following demonstration of activity. The primary endpoint for the trial is objective disease response using standardized criteria. Secondary objectives for the study include evaluation of safety, time to response, duration of response, and survival following single-agent therapy with PXD101.