PHARMION, METHYLGENE BEGIN PHASE II TRIAL OF MGCD0103 IN NHL

Pharmion, along with its partner MethylGene, has initiated a Phase II trial with of a histone deacetylase (HDAC) inhibitor product candidate, MGCD0103, in patients with relapsed or refractory B-cell lymphomas. Specific patient populations include patients with diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma, two tumor types that are classified as non-Hodgkin's lymphomas (NHL).

This open-label, single-agent trial will enroll up to 82 patients with DLBCL or follicular lymphoma for whom other treatments have failed or whose disease has relapsed. The trial will be conducted at several leading cancer centers in North America. MGCD0103 will be given orally, three times per week, without interruption at a flat dose of 110 mg. This dose was determined based on safety and efficacy data from the Phase I hematologic malignancy study.

Key objectives of the study will be to determine the effectiveness of MGCD0103 as a treatment option for these patients. Secondary objectives include determining the safety profile, as well as assessing biomarkers and predictive markers for MGCD0103. The trial is expected to last up to 24 months.

MGCD0103 is a rationally designed, oral, isotype-selective HDAC inhibitor. In addition to this trial, Pharmion and MethylGene continue to enroll patients in a Phase I single-agent trial evaluating MGCD0103 on a twice-weekly oral schedule, a Phase I/II combination trial with demethylating agent Vidaza (azacitidine for injectable suspension) in patients with advanced myelodysplastic syndrome or acute myelogenous leukemia and in a Phase II single-agent trial in patients with refractory or relapsed Hodgkin's lymphoma.