Pharmion reports some patients see bone marrow benefits with MGCD0103

New York, June 5 - Pharmion Corp. announced that interim data for MGCD0103 showed some cancer patients had a strong bone marrow response.

Researchers presented findings from two studies on the drug at the American Society of Clinical Oncology annual meeting in Atlanta, one evaluating MGCD0103 in patients with hematological cancers (leukemia and myelodysplastic syndromes), in which three of nine evaluable patients receiving the two highest doses achieved complete bone marrow responses, and the second study in patients with solid tumors, in which five patients experienced stable disease.

"We have seen clear marrow responses in patients with highly-refractory acute myelogenous leukemia. These are very exciting findings for this rationally-designed oral drug with excellent pharmacodynamic characteristics. Additionally, this agent has a manageable safety profile," G. Garcia-Manero, associate internist and associate professor of medicine at The University of Texas M.D. Anderson Cancer Center and a principal investigator of the MGCD0103 leukemia/ myelodysplastic syndromes trial, said in a news release.

MGCD0103 is an oral isotype-selective histone deacetylase inhibitor licensed from MethylGene, Inc.

For the phase 1 open-label study of MGCD 0103 in patients with leukemia or myelodysplastic syndromes, data on the 23 patients enrolled as of May was presented. The treatment was given as an oral monotherapy administered three-times weekly to patients with hematologic malignancies.

The maximum tolerated dose was exceeded at 80 mg/m2 with nausea, vomiting, diarrhea and/or fatigue as dose-limiting toxicities.

Two patients with refractory acute myelogenous leukemia and one patient with advanced myelodysplastic syndromes achieved complete bone marrow responses (bone marrow blast incidences were less than or equal to 5%).

Both pharmacokinetic evaluations and the measurement of histone deacetylase activity in peripheral white cells demonstrated a dose-dependent effect. Importantly, activity in patients was consistent with dose dependent inhibition of the histone deacetylase target, the company said.

In the second study, data was presented on the 28 patients enrolled as of May in the phase 1 open-label, dose-escalation study of MGCD0103 as an oral monotherapy administered three-times weekly to advanced solid tumor patients.

The maximum tolerated dose and the recommended phase 2 dose have not yet been determined.

The most common toxicity reported was grade 1-3 fatigue.

Three patients with kidney cancer, one patient with non-small cell lung cancer and one patient with colon cancer experienced stable disease. The half-life of MGCD0103 was nine hours, consistent with previous studies.

Studies are currently enrolling for a phase 1 monotherapy trial in hematological malignancies on a twice-weekly oral schedule and a phase 1/ 2 combination trial with Vidaza (azacitidine for injectable suspension) in patients with advanced myelodysplastic syndromes or acute myelogenous leukemia.

Pharmion, along with partners MethylGene and Taiho Pharmaceutical, expects to begin a phase 1/ 2 combination trial with an undisclosed chemotherapeutic and later in 2006 anticipates embarking on additional phase 2 monotherapy trials.

Pharmion is a Boulder, Colo.-based pharmaceutical company that acquires, develops and commercializes products for the treatment of hematology and oncology patients.

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