TopoTarget and CuraGen start first NCI-backed PXD101 trial

Denmark's TopoTarget A/S and CuraGen of the USA have announced the initiation of patient dosing in a new Phase I trial with their small-molecule histone deacetylase inhibitor, PXD101.

The trial is the first PXD101 study to be sponsored by the US National Cancer Institute and will evaluate the safety and tolerability of the product in combination with bortezomib (Millennium's Velcade) for the treatment of patients with advanced malignancies, including solid tumors and lymphomas. NCI-sponsored clinical trials with PXD101 are being conducted in parallel to those sponsored by CuraGen, including the Phase Ib/II study of PXD101 plus Velcade for the treatment of multiple myeloma initiated last week by TopoTarget and CuraGen.

This Phase I trial is an open-label, dose-escalation study being led by Gail Eckhardt, director of the developmental therapeutics and GI Malignancies programs and professor of medicine at the University of Colorado Health Sciences Center, USA. The study aims to establish the maximum tolerated dose (MTD) and the safety profile of PXD101 in combination with bortezomib, a proteasome inhibitor for patients with advanced solid tumors or lymphomas, which are refractory to standard therapies or for which no standard treatment exists.