Pharmion and MethylGene Start Phase 2 Combination Clinical Trial With MGCD0103 and Vidaza(R) in Patients With Relapsed or Refractory Hodgkin Lymphoma or Non-Hodgki...(and DirectorClinical Investigation and T...),Health

Date:1/9/2008

and Director, Clinical Investigation and Translational Research in the Department of Lymphoma/Myeloma, M.D. Anderson Cancer Center and a principal investigator for this trial. "There have been no new approved therapies in relapsed/refractory Hodgkin lymphoma for decades. As epigenetics is thought to play a role in lymphoma, this clinical study will help build an understanding of the role of HDAC inhibitors and demethylating agents in the treatment of non-Hodgkin and Hodgkin lymphoma."

Encouraging anti-tumor activity has been demonstrated in a Phase 2 clinical study of MGCD0103 as a single agent in the relapsed or refractory Hodgkin lymphoma patient population. Data from the ongoing study, presented at the American Society of Hematology (ASH) annual meeting last month, reported an objective complete and partial response (CR and PR) rate of 38 percent and a disease control rate of 43 percent in 21 evaluable patients in the 110mg cohort. Eighty-six percent of patients who had CT scans experienced a reduction in tumor size, with 57 percent experiencing a tumor reduction of greater than 30 percent. The two CR patients have a preliminary progression-free survival (PFS) of 14 and nine months at the time of analysis, and the range of PFS from the responder group is 56 to greater than 396 days. Adverse events associated with MGCD0103 administration of grade 3 or higher included pneumonia (15 percent), thrombocytopenia (12 percent) and fatigue (nine percent). Dose modification was effective in many of these patients.

About MGCD0103

MGCD0103 is an orally-administered, isotype-selective HDAC inhibitor. The compound is currently in one Phase 1 combination clinical trial with Taxotere(R) for solid tumors, two Phase 1/2 combination trials with Vidaza(R) for hematological malignancies and with Gemzar(R) for pancreatic cancer; and five Phase 2 clinical trials in hematological malignancies.

MGCD0103 has received orphan drug designation from the U.S. Food a
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