27th Jul 2018 11:11
LONDON (Alliance News) - Polarean Imaging PLC on Friday said it intends to conduct a phase III trial of its magnetic resonance imaging technique following successful completion of its pilot study.
The medical technology company said it completed the pilot study to validate the study design and analysis methods for its phase III trials of its radiology device.
Polarean intends to compare its 129-Xenon gas magnetic resonance imaging with a widely-used imaging technique 133Xe scintigraphy.
The company said it enrolled ten chronic obstructive pulmonary disease patients across a range of disease severity. Each patient underwent scanning by both 129-Xenon and 133Xe scintigraphy.
The results of the study showed that the chosen methodology is appropriate and should maximise the probability that both the primary and secondary endpoints of the Phase III Trials will accurately reflect the comparative values of 129-Xenon versus 133Xe scintigraphy.
Polarean said it plans to start phase III clinical trial in mid-August. The new study will comprise of 80 patients, who will be evaluated for lung lobe resection and lung transplant procedures.
The company said it expects data collection from the phase III trials to complete during the third quarter of 2019. If the trials are successful the company will submit its new drug application.
"We are pleased with the results of the pilot study," said Chief Executive Richard Hullihen. "We took the opportunity to reduce the risk in our pivotal trials by commissioning the pilot study to directly test the workflow and analytical and measurement methodology of our trials on ten patients."
Shares in Polarean were untraded on Friday, last quoted at 15.75 pence each.
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