MethylGene’s Leukemia Drug Receives EMEA’s Orphan Drug Designation
February 11, 2008
MethylGene and Pharmion have reported that the European Medicines Agency or EMEA and the European Commission, designated MGCD0103, a histone deacetylase inhibitor, as an orphan medicinal product for the treatment of acute myelogenous leukemia in the EU.
MGCD0103 is an orally-administered, isotype-selective HDAC inhibitor and is currently in one Phase I combination clinical trial with Taxotere for solid tumors, two Phase I/II combination trials with Vidaza for hematological malignancies and with Gemzar for pancreatic cancer, and five Phase II clinical trials in hematological malignancies.