TIDMPOLX
RNS Number : 2324B
Polarean Imaging PLC
29 January 2020
Polarean Imaging Plc
("Polarean" or the "Company")
Positive results from pivotal Phase III Clinical Trials
Both trials met their primary endpoint, showing pre-defined
equivalence of hyperpolarized (129) Xenon Gas MRI to an approved
comparator, (133) Xenon Scintigraphy
Company plans for NDA submission to FDA in Q3 2020
Polarean's technology could offer clinicians a powerful tool to
visualise 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, announces positive
top-line results from two pivotal Phase III clinical trials (the
"Clinical Trials") of the Company's drug-device combination, which
uses hyperpolarized (129) Xenon gas MRI to visualise and quantify
regional lung function.
The drug, (129) Xenon, when polarised in Polarean's proprietary
system, permits functional, regional and quantitative imaging of
the lungs using MRI, without the use of ionizing radiation. (129)
Xenon 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, but
derived from a different imaging modality.
Phase III Clinical Trials Data Demonstrate Effective Measurement
of Regional Lung Ventilation
The two Clinical Trials were multi-center, randomised,
open-label studies that compared MRI with (129) Xenon gas,
polarised in Polarean's system, to (133) Xenon scintigraphy. These
tests were used to measure regional pulmonary function in patients
being evaluated for possible lung resection surgery and possible
lung transplant surgery.
Both Clinical Trials met their primary endpoints, within the
prospectively defined equivalence margin (+/-14.7%) when compared
to the FDA-approved reference standard, (133) Xenon 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, this was expressed
as a percentage remaining function. The intra-patient mean
difference between (129) Xenon MRI-predicted remaining function and
(133) Xenon 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 (129) Xenon gas inhalation and the 10 second
breath 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).
Richard Hullihen, Chief Executive Officer of Polarean said: "The
positive results of these Clinical Trials validate our belief that
Polarean's technology allows clinicians to visualise aspects of the
lung function, which have never before been visible by MRI, both
safely and quantitatively. More than 30 million Americans suffer
from a chronic lung disease and the financial burden of lung
disease now exceeds US$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."
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 said: "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. The innovative approach
we have taken with the use of hyperpolarized (129) Xenon 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 Company's technology available as
an additional tool to potentially make a clinically significant
impact in the future."
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) 596/2014.
Contacts:
Polarean Imaging plc www.polarean.com / www.polarean-ir.com
Richard Hullihen, Chief Executive Via Walbrook PR
Officer
Richard Morgan, Chairman
SP Angel Corporate Finance Tel: +44 (0)20 3470 0470
LLP
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
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 (129) Xenon 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)
The Company 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 ((129) Xe) as an
imaging agent to visualize ventilation.(129) Xe 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 (129) Xe 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 (129) Xe in MRI equipment for use as a medical diagnostic as
well as a method of monitoring the efficacy of therapeutic
intervention.
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January 29, 2020 02:00 ET (07:00 GMT)
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