MethylGene Inc., a biopharmaceutical company focused on epigenetic regulation, has enrolled its first patient in a single-agent phase II clinical trial of its lead HDAC compound, MGCD0103, in patients with relapsed or refractory Hodgkin's lymphoma, a cancer initially located in the lymph nodes. The initiation of this phase II study results in milestone payments from the company's partners, Pharmion Corporation and Taiho Pharmaceutical, of US $4.0 million and US $1.5 million, respectively.
In this open-label trial, MGCD0103 will be given orally at a dose of 110 mg, three times per week to patients with Hodgkin's lymphoma who have failed other treatments or whose disease has relapsed. Key objectives of the study will be to determine the effectiveness of MGCD0103 as a treatment option for patients with refractory or relapsed Hodgkin's lymphoma. Effectiveness, or the success rate, will be measured by the combined total of complete responses; partial responses and patients who experience stable disease for six cycles or more (a cycle is equal to four weeks).
Secondary objectives include determining the safety profile, as well as assessing biomarkers and predictive markers for MGCD0103. The study is expected to enrol up to 35 patients at several leading cancer centres in North America and take approximately 12 to 15 months to complete.
"We are pleased to be steadily moving our HDAC cancer program forward and the initiation of this first phase II trial of our lead product candidate is an important achievement, resulting in US $5.5 million of milestone payments. In addition to studying MGCD0103 in Hodgkin's lymphoma, we expect to embark, with our partners Pharmion and Taiho, on additional phase II trials with our compound in other cancer indications where epigenetics appears to play a role," commented Donald F. Corcoran, President and CEO, MethylGene Inc.
"Epigenetic modulation by histone deacetylase appears to be critical in the pathobiology of Hodgkin's lymphoma. We are very enthusiastic about starting this trial in a patient population where there is a significant need for new therapies," commented Dr Anas Younes, Prof., Lymphoma Myeloma at MD Anderson Cancer Centre and lead investigator for this trial.