TopoTarget gets FDA go-ahead for Ph III SPA belinostat PTCL trial

Danish drug developer TopoTarget AS says it has received a positive reply from the US Food and Drug Administration concerning its Special Protocol Assessment for a Phase III trial for belinostat in peripheral T-cell lymphoma.

This pivotal trial is to enrol approximately 120 patients and is to begin in fourth-quarter 2008. In June, fast-track designation was granted for the development of the agent in this indication, which supports TopoTarget's rapid market entry strategy. There is currently no standard therapy approved for PTCL.

The Phase III trial is an open-label, multicenter, single-arm efficacy and safety study in patients with relapsed or refractory PTCL who have failed at least one prior systemic therapy. Patients will be treated with 1,000mg/m2 belinostat administered as a 30-minute IV infusion on days one to five of every three-week cycle until there is disease progression or unmanageable treatment-related toxicities.