Both trials met their primary endpoint, showing
pre-defined equivalence of hyperpolarized 129Xenon Gas MRI to an
approved comparator, 133Xenon Scintigraphy
Company plans for NDA submission to FDA in Q3
2020
Polarean’s technology could offer clinicians a
powerful tool to visualize lung function, overcoming limitations of
existing methods of diagnosis and monitoring treatment
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.”
“The use of conventional, anatomical MRI has, historically, not
played a role in addressing the substantial unmet need in working
up difficult-to-diagnose pulmonary diseases,” said Y. Michael Shim,
MD, Director of Pulmonary Rehabilitation and Director of the
Pulmonary Function Testing Lab at the University of Virginia, and
an investigator on the trials. “The innovative approach we have
taken with the use of hyperpolarized 129Xenon gas opens up a whole
new window into how physicians diagnose, stage and monitor
responses to treatment in a broad range of lung diseases with this
high resolution, non-ionizing MRI method. Based on what has been
demonstrated in these clinical trials, we are excited about the
prospect of having the technology available as an additional tool
to make a potentially clinically significant impact in the
future.”
About Polarean’s Technology
Polarean's technology produces hyperpolarized inert Xenon gas,
used in conjunction with standard MRI to create high-resolution
three-dimensional functional maps of the human lung. This technique
provides a unique and sensitive way to monitor changes in lung
structure and function; it is currently used in basic and clinical
research to study lung physiology and to monitor the efficacy of
new drugs.
The central equipment required for hyperpolarized gas MRI is a
polarizer. Using circularly polarized laser light, the polarizer
transforms the inert, stable noble gas isotope 129Xenon into its
hyperpolarized state. This process leaves the gas chemically
unchanged, while only the nucleus is magnetically aligned. The
resulting MRI signal is enhanced by a factor of 100,000, making
direct imaging of gas atoms possible.
About Polarean (www.polarean.com)
Polarean Imaging plc and its wholly owned subsidiary, Polarean,
Inc. (together the "Group") are revenue-generating, medical
drug-device combination companies operating in the high-resolution
medical imaging market.
The Group develops equipment that enables existing MRI systems
to achieve an improved level of pulmonary function imaging and
specializes in the use of hyperpolarized Xenon gas (129Xe) as an
imaging agent to visualize ventilation.129Xe gas is currently being
studied for visualization of gas exchange regionally in the
smallest airways of the lungs, the tissue barrier between the lung,
and the bloodstream and in the pulmonary vasculature. Xenon gas
exhibits solubility and signal properties that enable it to be
imaged within other tissues and organs.
The Group also develops and manufactures high performance MRI
radiofrequency (RF) coils which are a required component for
imaging 129Xe in the MRI system. The development of these coils by
the Group facilitates the adoption of the Xenon technology by
providing application-specific RF coils which optimize the imaging
of 129Xe in MRI equipment for use as a medical diagnostic as well
as a method of monitoring the efficacy of therapeutic
intervention.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200129005421/en/
For Media: Lindsey Bailys Tel: +1 786-252-1702 or
lindsey.bailys@gcihealth.com
Polarean Imaging plc www.polarean.com /
www.polarean-ir.com Richard Hullihen, Chief Executive Officer Via
Walbrook PR Richard Morgan, Chairman
SP Angel Corporate Finance LLP Tel: +44 (0)20 3470 0470
David Hignell / Soltan Tagiev (Corporate Finance) Vadim Alexandre /
Rob Rees (Corporate Broking)
Walbrook PR Tel: +44 (0)20 7933 8780 or
polarean@walbrookpr.com Paul McManus / Anna Dunphy Mob: +44 (0)7980
541 893 / +44 (0)7879 741 001
Polarean Imaging (LSE:POLX)
Gráfica de Acción Histórica
De Mar 2024 a Abr 2024
Polarean Imaging (LSE:POLX)
Gráfica de Acción Histórica
De Abr 2023 a Abr 2024