PXD101 fares well with retinoic acid in Ph I trial

Copenhagen, Denmark-based TopoTarget AS and the USA's CuraGen Corp have initiated patient dosing in a Phase I clinical trial evaluating the safety and tolerability of their small-molecule histone deacetylase inhibitor, PXD101, in combination with cis-retinoic acid for the treatment of patients with advanced solid tumors.

This Phase I trial, which is being sponsored by the US National Cancer Institute, is an open-label, dose-escalating study that aims to establish the maximum tolerated dose and safety profile of the agent in combination with cis-retinoic acid in advanced solid tumors, which are refractory to standard therapies or for which no standard treatment exists.

Up to 24 patients will be enrolled in the study and receive therapy in continuous three-week cycles until disease progression. Following determination of the MTD, the study will enroll approximately 10 additional patients to further assess the pharmacokinetics of PXD101, both alone and when administered concurrently with cis-retinoic acid.