January 29, 2020
Polarean Imaging plc Announces Positive Results From Pivotal Phase III Clinical Trials
Polarean Imaging plc (AIM: POLX), a clinical stage medical imaging technology company developing a proprietary magnetic resonance imaging (MRI) drug-device combination, today announced positive top-line results from two pivotal Phase III clinical trials of the Company’s drug-device combination, which uses hyperpolarized 129Xenon gas MRI to visualize and quantify regional lung function.
The drug, 129Xenon, when polarized in Polarean’s proprietary system, permits functional, regional and quantitative imaging of the lungs using MRI, without the use of ionizing radiation. 129Xenon is administered as an inhaled gas that is given to patients in a 10-second breath-hold procedure. For patients who participated in the clinical trials, the ventilation in zones of interest was quantified and compared to images, similarly quantified, derived from a different imaging modality.
Phase III Clinical Trials Demonstrate Effective Measurement of Regional Lung Ventilation
The two clinical trials were multi-center, randomized, open-label studies that compared MRI with 129Xenon gas, polarized in Polarean’s system, to 133Xenon scintigraphy. These tests were used to measure regional pulmonary function in patients being evaluated for possible lung resection surgery and possible lung transplant surgery, respectively.
Both clinical trials met their primary endpoints within the prospectively defined equivalence margin (+/-14.7%) when compared to the FDA-approved reference standard, 133Xenon scintigraphy imaging.
Lung Resection Trial
The surgical resection trial of 32 patients required investigators to specify lung zones that would likely be resected if the patient received resection surgery. This trial compared each imaging modality’s prediction of the proportion of lung function that would remain if the zone(s) were removed, expressed as a percentage of remaining function. The intra-patient mean difference between 129Xenon MRI-predicted remaining function and 133Xenon scintigraphy-predicted remaining function was 1.4% with a 95% confidence interval of (‑0.75%, 3.60%).
Lung Transplant Trial
In the lung transplant trial of 48 patients, the intra-patient mean difference between the imaging modalities’ measurement of the contribution of right lung to total lung function (percentage function) was -1.59% with a 95% confidence interval of (-3.69%, 0.50%).
Hyperpolarized 129Xenon gas inhalation and the 10-second breath-hold procedure were well tolerated. Data from these clinical trials are being submitted for presentation at an upcoming scientific conference.
In addition, data from the clinical trials will form the basis of a Pre-New Drug Application (NDA) Meeting with the U.S. Food and Drug Administration (FDA). Following the Pre-NDA Meeting and incorporation of the conclusions of the Clinical Trials into the NDA submission, Polarean plans to submit an NDA for the drug-device combination to the FDA, which is now estimated for Q3 2020.
More information on these studies can be found on www.clinicaltrials.gov under the identifiers NCT03417687 (lung resection) and NCT03418090 (lung transplant).
“The positive results of these clinical trials validate our belief that Polarean’s technology allows clinicians to visualize aspects of lung function, which have never before been visible by MRI, both safely and quantitatively,” said Richard Hullihen, Chief Executive Officer of Polarean. “More than 30 million Americans suffer from a chronic lung disease, and the financial burden of lung disease now exceeds $150 billion annually. Given the limitations of existing methods to diagnose and monitor lung disease, we see a significant unmet need for non-invasive, quantitative and cost-effective image-based diagnosis technology without exposing patients to ionizing radiation. We believe that our technology has the potential to overcome these limitations and we look forward to using data from the clinical trials to support our New Drug Application.”
[Originally posted by Business Wire — Jan 29, 2020]