Polarean Imaging PLC Company update (9433V)
27 July 2018 - 4:00PM
UK Regulatory
TIDMPOLX
RNS Number : 9433V
Polarean Imaging PLC
27 July 2018
Polarean Imaging Plc
("Polarean" or the "Company")
Company Update
Polarean Imaging plc (AIM: POLX), the medical-imaging technology
company, with a proprietary drug-device combination product for the
magnetic resonance imaging (MRI) market, announces the allowance of
the latest patents on polarisation, the results of a 'pilot study'
(the "Pilot Study") that was undertaken in preparation for its
upcoming Phase III Clinical Trials and an update regarding the
Company's Phase III Clinical Trials.
Highlights:
-- Patent Allowance - The Company has received Notice of
Allowance on the latest U.S. Patent Application No. 15/120,013
"Hyperpolarized Noble Gas Production Systems with Nanocluster
Suppression, Detection, and/or Filtering and Related Methods and
Devices" to which it has exclusive rights. This patent, together
with the Company's know-how, has led to increasing levels of
polarisation for its gas-hyperpolarisation platform for MRI. This
is key to advancing image quality, exploring new applications and
increasing the overall efficiency of the Company's polarisers.
-- Completion of Pilot Study prior to Phase III Clinical Trials
- In anticipation of its Phase III Trials comparing hyperpolarised
129-Xenon gas MRI ("129Xe MRI") to 133Xe scintigraphy (a
widely-used imaging technique), Polarean commissioned a Pilot Study
at one of its Trial sites. The Pilot Study was conducted to
validate the study design and the proposed analysis methods of its
Phase III Trials along with the proposed analytical methods that
will be used in the Trials. The Pilot Study enrolled ten COPD
patients across a range of disease severity. Each patient underwent
scanning by both 129Xe MRI and 133Xe scintigraphy. COPD patients
were selected for the Pilot Study due to their expected similarity
to the patients that will participate in the Phase III Trials and
the relative ease of their recruitment. All scanning protocols were
identical to those that will be used in the Phase III Trials. The
scans for each modality were quantified by a standard 6-zone
analysis to calculate the percentage of lung function contributed
by each of the 6 lung zones, as well as the total right lung
function. This Pilot Study of ten patients, which is representative
of population for the Phase III Trials, gives the Company
confidence in its trial design, i.e. the chosen methodology is
appropriate and should maximise the probability that both the
primary and secondary endpoints of the Phase III Trials will
accurately reflect the comparative values of 129Xe MRI versus 133Xe
scintigraphy.
-- Phase III Clinical Trials update - Polarean's Phase III
Clinical Trials are now scheduled to start in mid-August 2018. They
are 'head to head' non-inferiority trials versus 133Xe
scintigraphy, with the aim to pursue a "structural claim" for the
use of its product as a contrast agent. The Phase III Trials will
evaluate two patient populations: candidate patients for (1) lung
lobe resection and (2) lung transplant procedures, and will total
80 patients in aggregate. In those populations, lung function
information will be obtained and non-inferiority against 133Xe
scintigraphy will be compared.
Polarean currently expects data collection for the Phase III
Trials to complete during Q3 of 2019 and if the Trials are
successful the Company aims to submit its New Drug Application
("NDA") with the same claim as the approved comparator 133Xe drug,
"for the evaluation of pulmonary function, for imaging the lungs"
shortly thereafter.
Richard Hullihen, CEO of Polarean, commented:
"Polarean is a drug-device company and will undertake 'head to
head' non-inferiority Clinical Trials. We took the opportunity to
reduce the risk in our pivotal trials by commissioning the Pilot
Study to directly test the workflow and analytical and measurement
methodology of our Trials on ten patients which comprise 25% of
each indication's trial population. We are pleased with the results
of the Pilot Study and look forward to providing further updates
regarding the Phase III Trials as appropriate."
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) 596/2014.
Enquiries:
Polarean Imaging plc www.polarean.com / www.polarean-ir.com
Richard Hullihen, Chief Executive Officer Via Walbrook PR
Richard Morgan, Chairman
Northland Capital Partners Limited Tel: +44 (0)20 3861
6625
David Hignell / Gerry Beaney / Jamie Spotswood
(Corporate Finance)
Vadim Alexandre / Rob Rees (Corporate Broking)
MC Services (European IR) Tel: +49 (0)89 210
2280
Raimund Gabriel
The Life Sciences Division (Financial Adviser)
Navid Malik, Director Mob: 07957 224 730
Alia Minhas, CEO Mob: 07590 696 057
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
Helen Cresswell 741 001
Mob: +44 (0)7841 917 679
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END
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