Mocetinostat: Phase II started

Mirati began an open-label Phase II trial to evaluate 70 and 90 mg oral mocetinostat plus azacitidine in about 30 patients with MDS. In 2H14, the company plans to start a Phase III trial with 90 mg mocetinostat in combination with azacitidine for first-line treatment of MDS. Mirati said it will seek an SPA from FDA for the trial. Mocetinostat has Orphan Drug designation in the U.S. and EU to treat Hodgkin's lymphoma and acute myelogenous leukemia (AML).

In 2009, FDA lifted a partial clinical hold on mocetinostat for cancer after Mirati (formerly MethylGene Inc.) submitted safety data and analyses for all patients treated with the compound that showed there was no clear correlation between mocetinostat exposure and pericarditis or pericardial effusion (see BioCentury, Sept. 28, 2009). FDA placed mocetinostat on clinical hold in July 2008 after cases of pericarditis or pericardial effusion were seen in clinical trials (see BioCentury, July 28, 2008). ...