Pharmion and MethylGene Report Preliminary MGCD0103 Clinical Data at the 2007 AACR-NCI-EORTC International ...(administered together at the recommended...),Health

Date:10/24/2007

administered together at the recommended doses. The MTD was reached and the Companies have initiated the Phase II portion of the study with a recommended dose of 90mg of MGCD0103 in patients with pancreatic cancer. In addition, the pharmacokinetic profile of MGCD0103 appeared not to be altered when administered in combination with Gemzar.

Of the 21 patients enrolled in the study, 13 were evaluable for efficacy at the time of analysis. In summary, of the 13 evaluable patients there was one partial response (PR - RECIST criteria, unidimensional greater than or equal to 30% shrinkage) and eight stable disease (SD). In addition, five of the 13 evaluable patients experienced tumor shrinkage. The PR and a near PR (SD with 29% tumor shrinkage) were observed in pancreatic cancer patients, both of whom remain on study having received six and three cycles of treatment, respectively. Importantly, of the four evaluable patients with pancreatic cancer, there was one PR and three SD, which includes the one near PR.

"MGCD0103 is a very interesting compound as it is the first rationally-designed isotype-selective HDAC inhibitor in clinical development," said Dr. Herbert Hurwitz. "The current study is meant to follow up on strong preclinical data in pancreatic cancer, including synergy with gemcitabine. The Phase I stage of this study shows that the combination of MGCD0103 with gemcitabine is safe with preliminary signs of efficacy in pancreatic cancer. The Phase II stage of the study has been initiated and will better define the potential role of MGCD0103 in patients with pancreatic cancer."

"We are pleased to observe the preliminary tolerability and early signs of clinical activity for the MGCD0103 and Gemzar combination in solid tumor patients and particularly in pancreatic cancer patients. We look forward to expanding our enrollment in this underserved patient population and moving this trial forward during 2008," said Donald F. Corcoran, President and Chief Ex
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