Polarean Imaging PLC 3rd tranche of $3m pediatric study grant confirmed (6262Z)
21 Mayo 2019 - 01:01AM
UK Regulatory
TIDMPOLX
RNS Number : 6262Z
Polarean Imaging PLC
21 May 2019
Polarean Imaging Plc
("Polarean" or the "Company")
Third tranche of $3m paediatric lung disease imaging study grant
confirmed
Phase III trial with Cincinnati Children's Hospital, one of the
top pediatric centres in the US
Trial could support the routine application of xenon imaging to
Cystic Fibrosis treatment for children
Polarean Imaging plc (AIM:POLX), the clinical stage
medical-imaging technology company, with a proprietary drug-device
combination product for the magnetic resonance imaging (MRI)
market, announces that it will receive a third tranche of US$1
million as part of its US$3 million Small Business Innovation
Research ("SBIR") grant. The funds will be used to continue a Phase
III trial evaluating the use of 129 Xe MRI scanning for children
being treated for Cystic Fibrosis ("CF").
The successful conclusion of this trial, which is being
performed at Cincinnati Children's Hospital, one of the US's
leading children's hospitals, could provide data to support the
routine use of Polarean's 129 Xe MRI imaging technology for more
accurate monitoring of lung function during CF treatment. CF is a
genetic disease which can lead to impaired lung function and death.
In the US alone, there are currently over 30,000 people with CF
(Cystic Fibrosis Foundation Patient Registry).
Collaboration with Cincinnati Children's Hospital Medical Center
("Cincinnati Children's")
The SBIR grant was awarded from the National Heart, Lung and
Blood Institute ("NHLBI"), part of the US National Institutes of
Health (NIH). The Grant was jointly awarded to the Company and
Cincinnati Children's (www.cincinnatichildrens.org) and will
continue to fund an ongoing Phase III trial. The trial aims to
evaluate the use of 129 Xe MRI scanning for CF patients as a means
to provide more information to clinicians on lung function than is
currently achievable with standard clinical tests.
The Company and Cincinnati Children's have a long-standing
relationship regarding the development of 129 Xe MRI imaging and
its paediatric research applications, including the treatment of
CF. Cincinnati Children's is ranked as the third best US hospital
for Paediatric Pulmonology and Lung Surgery according to US News
& World Report, the global authority in hospital rankings.
Jason Woods PhD, Director of the Center for Pulmonary Imaging
Research at Cincinnati Children's, is a leader in developing safer
lung imaging methods for children.
Jason Woods PhD, Cincinnati Children's said: "Year three of this
NIH proposal will allow us to fully validate the hypothesis that
hyperpolarized Xe MRI is sensitive to mild lung-function declines
associated with CF in children. We anticipate that this work
programme will be a launching point for future studies that will
use the technique as a primary or secondary endpoint to demonstrate
efficacy of therapeutic agents in CF and other obstructive lung
diseases."
Richard Hullihen, CEO of Polarean said: "We are pleased to have
received this continued award for developing biomarkers for CF with
Dr. Woods and his team at Cincinnati Children's, one of Polarean's
long-standing collaborators. This includes deploying recent
developments in our gas exchange and red blood cell imaging
techniques using 129 Xe MRI. There are several new drug therapies
under development by manufacturers and a key element in expediting
the development and commercialisation process is having
quantitative, reproducible, non-invasive imaging-based biomarkers.
These biomarkers could reduce the cost of trials and maximise the
outcome and proof of cost efficacy in this critical patient
population. Achieving these milestones may facilitate expansion of
the developed techniques to other members of the Xenon MRI Trials
Consortium for multi-centre trials. We believe the applications
being developed in CF could further expand the use of 129-Xe
imaging as we continue to progress our own Phase III Clinical
Trials, which are testing our drug-device combination for the
evaluation of pulmonary ventilation."
Background to the SBIR grant
As described in the Company's Admission Document dated 23 March
2018, in April 2017, the NHLBI awarded Polarean a provisional
three-year SBIR grant of US$3m for a project entitled 'A Phase III
Trial to Validate HP 129Xe MRI as a Functional Pulmonary Biomarker
in Pediatric Lung Disease', for which the research would be
conducted with Cincinnati Children's. The grant was payable in
three tranches of US$1 million each year so long as Polarean
continued to meet the grant's terms and applicable US law and
regulation. The Company has received confirmation that it will be
receiving the third tranche of US$1million.
For more information on the Xenon MRI Trials Consortium see:
https://cpir.cchmc.org/XeMRICTC
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
SP Angel Corporate Finance LLP Tel: +44 (0)20 3470 0470
David Hignell / Lindsay Mair / Jamie Spotswood
(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
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END
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