7th Nov 2019 12:28
(Alliance News) - Polarean Imaging PLC said Thursday it has completed the enrolment for its Phase III non-inferiority clinical trials for both lung transplant and resection, meaning removal of all or part of a lung.
The medical-imaging technology company said a total of 80 patients were enrolled, of which 48 were in the lung transplant pathway and 32 in the lung resection pathway.
The aim of the clinical trial is to demonstrate non-inferiority of the company's drug-device combination, which uses hyperpolarised 129-Xenon gas MRI, against an approved comparator for the diagnostic evaluation of pulmonary ventilation, the company said.
The next stage of the trial is statistical analysis, which will form basis for a new drug application pre-meeting with the US Food & Drug Administration. Polarean expects to make its new drug application to the FDA by the end of the second quarter of 2020.
The company also announced the appointment of Alex Dusek as vice-president of commercialization with immediate effect.
Prior to joining Polarean, Dusek led multiple biopharmaceutical product launches in pulmonary disease, oncology cell therapy and HIV therapeutics, including at Bayer Healthcare and United Therapeutics, the company said.
Polarean Imaging shares were down 11% in London at 20.44 pence each on Thursday at midday.
By Loreta Juodagalvyte; [email protected]
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