MethylGene says studies on MGCD0103 show promising anti-cancer activity in leukemia patients

By E. Janene Geiss

Philadelphia, Dec. 8 - MethylGene Inc. announced preliminary and interim results for MGCD0103, its oral isotypic-selective HDAC inhibitor for cancer, that show promising anti-leukemia activity.

The company reported preliminary and interim data on the first 15 patients with highly resistant acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS), according to a company news release.

Four of seven patients treated at the two highest dose levels (60 and 80 mg/m2), after receiving one or two cycles of MGCD0103, have had reductions in bone marrow blasts with treatment ongoing in three of these patients, officials said.

In this trial, four dose levels have been evaluated with MGCD0103. Dose-limiting toxicities were gastrointestinal in nature at 80mg/m2.

Patients are now being treated with 60mg/m2, a dose which appears to be well-tolerated, provides pharmacodynamic activity on the target and exhibits anti-leukemia activity, officials said.

Patient enrollment continues at 60mg, officials said.

"At the current dose level of our oral agent, MGCD0103, we are seeing single-agent anti-leukemia activity," Robert E. Martell, vice president and chief medical officer for MethylGene, said in the release.

"These data are preliminary with more data to be gathered to classify these patients as responders according to formal criteria. However, we are encouraged by these early results and believe that they may help define a patient population that could benefit from treatment with MGCD0103," Martell added.

The data will be presented this week at the American Society of Hematology's annual conference in Atlanta.

MethylGene said it initiated a second hematology trial in October administering MGCD0103 twice per week to patients with MDS, AML and acute lymphocytic leukemia. The company said it also is exploring combination phase 1 /2 trials using MGCD0103 with other chemotherapeutics such as azacitidine (Vidaza), a demethylating agent, and other undisclosed agents.

MethylGene is a Montreal, Quebec, biotechnology company focused on development and commercialization of novel therapeutics in cancer and infectious disease.

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