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MethylGene initiates Phase II MDS and leukemia trial

MethylGene has initiated a Phase II clinical trial evaluating MGCD0103, an isoform-selective histone deacetylase inhibitor product candidate, in combination with Vidaza, a DNA demethylating agent, in patients with high-risk myelodysplastic syndromes or acute myeloid leukemia.

The study is a three-arm, randomized trial which will enroll up to 180 patients at cancer centers in North America and Europe.

Charles Craddock, professor of haemato-oncology at University of Birmingham, UK, said: “Vidaza recently demonstrated a major survival benefit when used to treat patients with high-risk myelodysplastic syndromes (MDS).

“The Phase I/II data with this combination were also compelling, and we aim to determine definitively whether combination treatment is superior to monotherapy in MDS and acute myeloid leukemia.”