MethylGene says results from MGCD0103 phase 1 trial in cancer patients shows disease stabilization

By E. Janene Geiss

Philadelphia, Nov. 15 - MethylGene Inc. said Tuesday that interim results from a phase 1 solid tumor trial of MGCD0103 showed prolonged disease stabilization in three patients with the most significant side effect being reversible fatigue.

The study demonstrated a lack of significant hematological and cardiac side effects, an important feature, officials said in a company news release.

MGCD0103 is a novel isotypic-selective inhibitor of the enzyme histone deacetylase (HDAC).

HDAC inhibitors act by turning on tumor suppressor genes that have been inappropriately turned off. Tumor suppressor genes are a natural defense against cancer. The company's hypothesis is that specifically inhibiting those HDACs involved in cancer with MGCD0103 may restore normal cell function and reduce or inhibit tumor growth.

In the study, MGCD0103 is administered orally three times a week for two weeks every three weeks in 26 patients with solid tumors, officials said. Tumor types investigated included colorectal, kidney, lung and others.

MGCD0103 has been well-tolerated with fatigue being the most common side effect in the first 22 patients, officials said. Other side effects included nausea and vomiting, anorexia and constipation.

Prolonged stabilization of disease was observed in two kidney cancer patients and one colorectal cancer patient. The maximum tolerated dose has not yet been reached and patient enrollment continues at a dose of 45 mg, officials said.

The interim results were presented Tuesday in two poster presentations at the annual European Organization for Research and Treatment of Cancer, National Cancer Institute, American Association for Cancer Research International Conference on Molecular Targets and Cancer Therapeutics in Philadelphia.

Montreal-based MethylGene is a biopharmaceutical company focused on discovery and commercialization of novel therapeutics in cancer and infectious disease.

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