The US Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for Marshall Edwards' mitochondrial inhibitor, ME-344, used for the treatment of tumours.
ME-344 is the mitochondrial inhibitor and an active metabolite of NV-128, and is currently being investigated in a Phase I clinical trial in patients with solid refractory tumours.
The open-label dose-escalation Phase I clinical trial will enrol up to 24 patients who will be administered intravenous infusions of ME-344 once weekly for three weeks and, after safety assessment, may continue weekly dosing if a clinical benefit is determined.
The ME-344 Phase I study, which is being conducted in collaboration with the Sarah Cannon Research Institute, will assess the pharmacokinetic profile, safety and tolerability of intravenous ME-344 in patients with refractory solid tumours.
Marshall Edwards president and CEO Daniel Gold said they have now successfully advanced the company's two promising oncology drug candidates into the clinic.
"As we near the completion of our Phase I clinical trial of ME-143 and prepare for its next phase of development, we are excited to initiate our first human study of ME-344," Gold added.
"We believe ME-344 is a novel compound that has the potential to significantly improve treatment outcomes for patients with cancer, but first it is important to confirm its safety and tolerability in patients while establishing an optimal dose for future trials."
In pre-clinical studies, ME-344 has demonstrated superior anti-tumour activity against a range of human cancer cell lines compared to NV-128, including breast, colorectal and ovarian.
Additionally, the company's drug candidates, ME-143 and ME-344, have been found to interact with specific enzyme targets resulting in inhibition of tumour cell metabolism, a function critical for cancer cell survival.
Image: Marshall Edwards' ME-344 product has received IND acceptance from the FDA. Photo: FDA.