TopoTarget/Curagen's PXD101 enters Ph I/II trial

Copenhagen, Denmark-based TopoTarget AS and the USA's CuraGen Corp have initiated patient dosing in a Phase I/II clinical trial evaluating the safety and potential efficacy of PXD101, a small-molecule histone deacetylase inhibitor, for the treatment of inoperable hepatocellular cancer.

The first part of the Phase I/II open-label trial aims to establish the maximum tolerated dose, pharmacokinetics, and safety profile of the agent. Approximately 15 subjects will be enrolled in the dose escalation portion of the study and receive PXD101 in continuous three-week cycles until disease progression.

Following determination of the MTD, the Phase II stage will be initiated and will enroll up to 29 additional patients to assess the safety and potential efficacy of PXD101. TopoTarget stressed that the initiation of the trial will not affect its financial expectations for full-year 2006.