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news.US-based MEI Pharma has dosed the first patient in a cohort-expansion stage of its Phase Ib clinical trial of ME-344 in combination with topotecan to treat patients with small cell lung or ovarian cancer who failed initial therapy.
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The company said that the cohort expansion comes after the initial stage of the trial confirmed that the maximum tolerated dose (MTD) of ME-344 in combination with topotecan is 10mg/kg, the same dose defined for single agent use.
As part of the cohort-expansion stage, the trial will enroll an additional 40 patients into two cohorts, locally advanced or metastatic small cell lung cancer and ovarian cancer.
MEI Pharma chief medical officer Dr Robert Mass said: "This milestone represents another important step forward for the clinical development of ME-344.
"While we remain focused on our lead drug candidate Pracinostat, we continue to be very excited by the potential of this novel mitochondrial inhibitor.
"ME-344 has shown broad and potent anti-tumor activity in pre-clinical studies, followed by promising single-agent activity in the clinic. Now we look forward to assessing its clinical activity in combination with chemotherapy and reporting on its progress in the months ahead."
The Phase Ib trial is designed to assess the combination of intravenous ME-344 and topotecan (Hycamtin).
After the initial stage of the trial, an independent Safety Committee determined the recommended Phase II dose for continued testing of ME-344 to be 10mg/kg in combination with 4mg/m2 of topotecan.
Hycamtin is a drug approved by the US Food and Drug Administration (FDA) to treat small cell lung, ovarian and cervical cancers.
The company said that the combination of ME-344 and topotecan has been generally well tolerated and the most frequent side effects noticed were fatigue and gastrointestinal disturbances.