Lymphoma drug gets EU Orphan Status

USA-based oncology firm Pharmion and Canada's MethylGene say that their co-developed Hodgkin's lymphoma drug candidate, MGCD0103, has been designated as an Orphan Medicinal Product by the European Medicines Agency (EMEA).

Preliminary data from a Phase II study, which were presented at this year's meeting of the American Society of Clinical Oncology (Marketletters passim), showed that MGCD0103 achieved objective complete response and partial response rates of around 40% in patients with refractory or relapsed forms of the disease. Additionally, the drug demonstrated a disease-control rate, defined as a complete response plus occurrence of stable disease for six or more treatment cycles, of 45%.

Pharmion and MethylGene, which have been collaborating on the development of histone deacetylase inhibitors since early last year (Marketletter February 6, 2006), welcomed the EMEA's decision. They added that the drug is currently being examined in a variety of indications, including: in two Phase I/II trials in patients with hematological malignancies in combination with Pharmion's oncology agent Vidaza (azacitidine for injectable suspension); as an addition to Eli Lilly's Gemzar (gemcitabine HCl) in the treatment of solid tumors; and in four Phase II studies as a monotherapeutic for hematological malignancies.