Pharmion, MethylGene Obtain Orphan Drug Status for MGCD0103

Pharmion and its collaborator MethylGene announced that the FDA has designated the companies’ histone deacetylase inhibitor as an orphan drug for the treatment of relapsed and refractory Hodgkin’s lymphoma in the U.S.

Preliminary data from a MGCD0103 Phase II monotherapy clinical trial were included in the application for orphan drug designation. The data demonstrated an objective complete response plus partial response rate of 40 percent and a disease control rate of 45 percent in a population of 20 evaluable patients, Pharmion and MethylGene said.

Fatigue and gastrointestinal side effects were the most common adverse events and dose modification was effective in many of these patients, the companies added.