TopoTarget/CuraGen expand CTCL arm of PXD101 trial

Copenhagen, Denmark-based TopoTarget AS and the USA's CuraGen have reviewed interim efficacy and safety data from an ongoing open-label trial evaluating belinostat (PXD101) monotherapy for the treatment of cutaneous T-cell lymphoma (CTCL) and found that the observed preliminary objective response rates have met the predefined criteria for expansion of the CTCL arm.

The protocol required at least two objective responses to be observed in the first 13 patients treated, which was achieved, and so, the trial will now enroll up to a total of 34 patients with CTCL to further evaluate the single agent activity of intravenous belinostat (PXD101) for the treatment of this cancer. The firms noted that the final data will help them identify the most promising indications during 2007 in order to initiate registrational studies in 2008.