New drug in phase II trial for peripheral T-cell lymphoma

Gloucester Pharmaceuticals reported on data from a clinical trial in patients with cutaneous T-cell lymphoma of its lead product candidate, FK228 (depsipeptide), presented at the ASCO Meeting held recently in Orlando, Florida. The studies were sponsored by the US NCI and conducted under a Cooperative Research and Development Agreement (CRADA) between Gloucester Pharmaceuticals and the NCI.



Richard Piekarz, M.D., Ph.D. of the NCI presented data in "Response and molecular markers in patients with peripheral T-cell lymphoma (PCTL) treated on a phase II trial of depsipeptide, FK228." Objective responses were observed in 5 of 19 patients with relapsed or refractory PTCL, including 2 complete responses and 3 partial responses. The duration of response ranged from 8-14 months, with one patient having an ongoing, complete response at 14 months.



"Peripheral T-cell lymphoma is one of several aggressive forms of non-Hodgkin's lymphoma," commented William McCulloch, M.B., FRCP, VP and Chief Medical Officer at Gloucester Pharmaceuticals. "At the time of diagnosis these lymphomas are often at relatively advanced stages, and require prompt treatment. The data presented by Dr. Piekarz demonstrate that, in the trial, FK228 had significant activity when used as single-agent therapy for patients with PTCL who have been unresponsive to current treatments."