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Pharmion and MethylGene Present Favorable Clinical Data From Combination MGCD0103/Vidaza(R) Study in Myelodysplastic Syndromes and Acute Myelogenous Leukemia at The 49th American Society of Hematology (ASH) Meeting
Date:12/10/2007

dy provide the basis for our planned three-arm randomized study of MGCD0103 and Vidaza in AML and MDS patients."

The study entitled, "Phase I/II study of MGCD0103, an oral isotype-selective histone deacetylase (HDAC) Inhibitor, in combination with 5-azacitidine in myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML)", Abstract #444 (Trial 005) was delivered as an oral presentation 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 Center.

Patients with MDS, relapsed/refractory AML, or untreated patients with AML were given Vidaza at its approved dose/schedule (75 mg/m2 SC daily for the first 7 days of a 28 day cycle). MGCD0103 was added orally three-times a week starting on the fifth day of Vidaza administration.

Of the 52 evaluable patients treated at all dose levels in the study (43 patients with AML and 9 with MDS), 36 percent (19 patients) demonstrated objective responses to the combined treatment (eight complete responses [CR], ten complete responses with incomplete peripheral count recovery [CRi], and one partial response [PR]). Among the 19 patients receiving MGCD0103 at a dose of 90 mg, 10 (53 percent) achieved a response. Of the 52 evaluable patients, 71 percent had received prior therapy. Of particular note, in an overall survival analysis, patients with a response had a 66 percent reduction in the risk of death when compared to non-responders.

The most common grade 3 and 4 non-hematological toxicities in the study were fatigue and gastrointestinal in nature (e.g., nausea, vomiting, anorexia, diarrhea, dehydration). The recommended phase 2 dose for MGCD0103 was determined to be 90 mg.

Vidaza did not affect MGCD0103 pharmacokinetics, nor did co-administration of MGCD0103 impact the pharmacokinetics of Vidaza. A majority of patients exhibited a substantial reduction in PBMC HDAC act
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SOURCE Pharmion Corporation
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