Polarean Imaging progresses to Phase III trial of hyperpolarised 129-Xenon

Medical imaging technology company Polarean Imaging announced on Thursday that the first patient has been enrolled in its Phase III FDA clinical trial, which aims to demonstrate non-inferiority of its drug-device combination using hyperpolarised 129-Xenon (129Xe) gas MRI, against an approved comparator.

The AIM-traded firm said it was now in the process of the Phase III clinical trial.

It said the trial was a 'head-to-head' non-inferiority trial testing 129Xe MRI against 133-Xenon (133Xe) scintigraphy, and it would be evaluating two patient populations - candidate patients for lung lobe resection, and lung transplant procedures - for 80 patients in total.

The Phase III trial was taking place at two US sites - Duke University and the University of Virginia.

Polarean said the Phase III trial followed on from the completion of a pilot study in which 10 patients with COPD were assessed using both Polarean's technology and 133Xe scintigraphy.

In that study the design and analysis methods of the Phase III trial were successfully demonstrated.

“The entire company is thrilled to have initiated our Phase III trial, after all the hard work of preparation,” said Polarean chief executive Richard Hullihen.

“We would like to thank our shareholders for their support, without which this would not have been possible.

“We also thank our clinical and research collaborators as their skill and expertise has been invaluable in enabling us to reach this important milestone.”