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Clinical Data Reported on Vidaza in Hematologic Malignancies and,Advanced Solid Tumors

sor genes, thereby promoting tumor growth. MGCD0103 is an orally-administered, selective HDAC inhibitor, which targets specific class I HDAC isotypes. Preclinical data suggest that these HDAC isotypes are important in cancer biology and, consequently, such selective HDAC inhibitors may have increased efficacy and reduced toxicity compared to non-selective inhibitors.

Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML) (Trial 005)

Data presented in a poster session by Guillermo Garcia-Manero, M.D., principal investigator, Associate Professor of Medicine and Chief, Section of Myelodysplastic Syndromes, Department of Leukemia, M.D. Anderson Cancer Centre, demonstrated that combination treatment with MGCD0103 and Vidaza(r) (azacitidine for injection) resulted in a 30 percent response rate for all patients, and a 37 percent response rate in the active dose ranges previously reported. Of the 37 patients in this trial, eleven patients (two MDS patients and nine AML patients) experienced objective clinical responses. In addition, the combination therapy showed good pharmacodynamic properties and acceptable safety in these patients.

"MGCD0103 and Vidaza are two epigenetic agents that have demonstrated single-agent activity in AML and MDS," said Dr. Garcia-Manero. "In this study we found that these agents can be given together, and that the resulting clinical activity is better than expected from each agent alone."

"We are very encouraged by the single-agent activity to date in our Hodgkin's lymphoma trial. These patients have progressive disease after receiving multiple prior therapies and there are currently no approved alternative treatments available to them," said Donald F. Corcoran, President and Chief Executive Officer of MethylGene. "In addition, the responses in our Vidaza-MGCD0103 combination trial are consistent with our earlier data. The data from these two ongoing trials have given us potential direction for registratio
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