Ergomed Plc (LON:ERGO) told investors this afternoon that its partner CEL-SCI has been granted permission by the US Food and Drug Administration to resume its phase III clinical trial of Multikine in head and neck cancer.
Multikine is being studied as a potential first-line immunotherapy – i.e. before any other cancer treatment is given – that is aimed at harnessing the patient's own immune system to produce an anti-tumour response.
The FDA put a partial clinical hold on the study back in September after it raised concerns with CEL-SCI over the design and safety of the trial.
Those issues seem to have been put to bed now and clinical trial activities can now resume.
So far, 928 newly diagnosed head and neck cancer patients have been enrolled in the study and all the patients who have completed treatment continue to be followed for protocol specific outcomes, Ergomed said.
“We're very pleased to hear that the phase III study of Multikine in head and neck cancer has been approved for continuation by the FDA,” said Ergomed’s chief executive Dan Weng.
“Multikine addresses a significant unmet medical need and we look forward to continuing to work with CEL-SCI on what is the largest ever Phase III study in head and neck cancer.”
Ergomed shares were off 1% to 188p in afternoon trading.