August 7, 2019
Polarean Enrols First Patient At University Of Cincinnati Trial Site
Polarean Imaging PLC on Monday announced enrolment of the first patients in its third trial site at the University of Cincinnati in the US and is on track for its third quarter enrolment target.
Shares in medical-imaging technology firm Polarean were down 3.6% at 27.00 pence in mid-day trading in London.
The Cincinnati trial site was added in June in a bid to up enrolment rates for Polarean’s third phase clinical trials.
The trials seek to prove that Polarean’s drug-device combination using a hyperpolarised 129-Xenon gas MRI is not inferior to “an approved comparator” when its comes to evaluating pulmonary ventilation.
At this point, enrolment for the trials is now above 98% within “the lung transplant pathway” and exceeds 75% within “the lung lobe resection pathway” with 80 patients targeted to be enrolled in the trial. Polarean is on track to finish enrolment for its trials by the end of the third quarter of the year.
“The first patient enrolment at our additional trial site at [University of Cincinnati] provides reinforcement that we will deliver on our commitment to a timely completion of enrolment for the clinical trials. We remain focused on the completion of our new drug application and submission to the US Food & Drug Administration following readout of the clinical trials. We are funded to complete this and undertake post submission launch preparation and planning. I look forward to providing our shareholders with further updates regarding the clinical trials as they near completion,” said Chief Executive Richard Hullihen.
[Originally posted by Morning Star — August 5, 2019]