DSMB tells Gloucester to continue romidepsin study

Oncology focused US firm Gloucester Pharmaceuticals says that, following a planned safety review by an independent Data Safety Monitoring Board of its pivotal trial of romidepsin as a treatment for patients with cutaneous T-cell lymphoma, the DSMB recommended that it should continue the trial without any modifications. The Board had the same recommendation in each of three previous separate review meetings held in 2006.

Gloucester point out that romidepsin is a novel agent in a new class of anti-cancer drugs known as histone deacetylase inhibitors. The company is conducting a pivotal Phase II study of the agent for patients with CTCL and has initiated a pivotal Phase II trial for patients with peripheral T-cell lymphoma. Romidepsin has received Orphan Drug Designation from the Food and Drug Administration for the treatment of non-Hodgkin T-cell lymphomas, which includes CTCL and PTCL. In addition, the European Medicines Agency (EMEA) has issued Orphan status for the treatment of both CTCL and PTCL.