US-based oncology firm MEI Pharma has dosed its first patient in a Phase Ib clinical trial of its investigational mitochondrial inhibitor drug candidate ME-344 in combination with Hycamtin (topotecan) to treat patients with solid tumours, including small cell lung and ovarian cancers.
Sixty four patients are expected to be enrolled in the open-label trial with preliminary data scheduled to be released by the first quarter of 2015.
MEI Pharma chief medical officer Robert Mass said ME-344 is an exciting drug candidate with a unique mechanism of action.
"In pre-clinical studies, ME-344 showed broad and potent anti-tumour activity, including a model of chemotherapy-resistant ovarian cancer stem cells," Mass said.
"Our first-in-human clinical study demonstrated evidence of single-agent activity, including a sustained partial response in a heavily pre-treated patient with small cell lung cancer.
"We are excited to initiate this second clinical study in order to better assess the potential of ME-344 in combination with chemotherapy."
In October 2013, the company reported results from a Phase I clinical trial of ME-344, which showed preliminary evidence of single-agent activity in patients with refractory solid tumours, including eight of 21 evaluable patients who achieved stable disease or better.
In particular, one patient with small cell lung cancer achieved a confirmed partial response (PR) and still remains on study after more than 89 weeks.
The results showed that ME-344 was generally well-tolerated in the trial at doses equal to or less than 10mg/kg delivered on a weekly schedule for extended durations.
The company said that dose limiting toxicities were seen at both the 15mg/kg and 20mg/kg dose levels, consisting primarily of Grade III peripheral neuropathy.
Currently, the Phase Ib trial is assessing the safety and tolerability of intravenous ME-344 in combination with Hycamtin, a chemotherapy approved by the US Food and Drug Administration (FDA) to treat small cell lung, ovarian and cervical cancers.
Initial stage of the trial will establish the maximum tolerated dose (MTD) of ME-344 in combination with Hycamtin in about 24 patients and once the MTD has been determined, the trial will enrol an additional 40 patients into two cohorts: relapsed/refractory small cell lung cancer and platinum-refractory ovarian cancer.
The trial is being carried out in collaboration with the Sarah Cannon Research Institute at the University of Oklahoma in Oklahoma City and Tennessee Oncology in Nashville.
Image: Preliminary data from MEI Pharma's Phase Ib trial of ME-344 in combination with Hycamtin to treat patients with solid tumours is scheduled to be released by the first quarter of 2015. Photo: courtesy of jscreationzs/ FreeDigitalPhotos.net.