ME-344: Phase I data

An open-label, dose-escalation, U.S. Phase I trial showed that 5 of 21 evaluable patients with refractory solid tumors who received IV ME-344 experienced progression-free survival (PFS) (34 to 61+ weeks) that was at least twice the duration of their last prior treatment prior to study entry. One patient with small cell lung cancer (SCLC) achieved a confirmed partial response, with a 32% reduction in target lesions. Additionally, there were 7 cases of stable disease. ME-344 was generally well tolerated at doses of <=10 mg/kg. DLTs at the 15 and 20 mg/kg doses of ME-344 consisted primarily of grade 3 peripheral neuropathy. The trial enrolled 30 patients with refractory solid tumors to receive once-weekly 1.25, 2.5, 5, 10, 15 or 20 mg/kg ME-344 for the first 3 weeks of a 4-week cycle. The maximum tolerated dose (MTD) and recommended Phase II dose is once-weekly 10 mg/kg IV ME-344. Data were presented at the Molecular Targets and Cancer Therapeutics meeting in Boston. ...