MethylGene begins phase II trials for lymphoma treatment

The trial of MethylGene’s lead histone deacetylase (HDAC) inhibitor product candidate, MGCD0103, will use specific patient populations including 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 (Trial 008) 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 companies’ 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.

Many cases of DLBCL and follicular lymphoma exhibit disrupted HDAC-dependent epigenetic regulation of cancer-related genes. Small molecule HDAC inhibitors are thought to have anticancer activity by regulating aberrant gene expression and restoring gene expression to normal levels. In addition, recent scientific literature has reported clinical activity against DLBCL as a result of HDAC inhibition.

“The initiation of this trial further expands our HDAC program in cancer,” said Donald Corcoran, president and CEO of MethylGene. “MGCD0103 is currently being evaluated in several clinical trials for solid tumors and hematological cancer as a single-agent or in combination with approved agents. With our partners Pharmion and Taiho, we look forward to initiating several additional clinical trials with the compound by the end of the year.”