TIDMONC
RNS Number : 0072B
Oncimmune Holdings PLC
04 June 2019
The information contained within this announcement is deemed by
the Company to constitute inside information stipulated under the
Market Abuse Regulation (EU) No. 596/2014. Upon the publication of
this announcement via the Regulatory Information Service, this
inside information is now considered to be in the public
domain.
4 June 2019
Oncimmune Holdings plc
("Oncimmune" or the "Company")
Positive Top Line Results for Early Cancer Detection Test - Lung
Cancer Scotland ("ECLS") Study
-- ECLS study meets primary end-point - to assess the
effectiveness of EarlyCDT(R) -Lung test in reducing incidence of
patients with late-stage lung cancer at diagnosis, compared with
standard clinical practice
-- The ECLS study, conducted in Scotland with 12,210 patients,
is believed to be the largest randomised controlled study using
biomarkers for the detection of lung cancer
-- A submission on the full ECLS study is being prepared for a
leading peer-reviewed medical publication
-- Preparations are underway for a phased evaluation in Scotland
expected to recruit up to 200,000 patients each to be tested with
EarlyCDT-Lung to be supplied by Oncimmune on negotiated commercial
terms
Oncimmune Holdings plc (AIM: ONC.L), a leading global
immunodiagnostics group, today announces positive top line results
from the Early Cancer Detection Test - Lung Cancer Scotland
("ECLS") study. The ECLS study, believed to be the largest(1)
randomised controlled study for the early detection of lung cancer
using biomarkers, recruited 12,210 patients each of whom were
followed up for a minimum of two years.
The Company is pleased to report that the study met its primary
endpoint showing that the use of EarlyCDT-Lung with subsequent
X-ray and computerised tomography (CT) scan reduced the incidence
of patients with late-stage lung cancer(2) or unclassified
presentation at diagnosis, compared to standard clinical
practice.
The ECLS study, sponsored by the University of Dundee and NHS
Tayside and co-funded by the Chief Scientist Office, Scottish
Government and Oncimmune was headed by Principal Investigators,
Professor Frank Sullivan, Professor of Primary Care Medicine at the
University of St. Andrews and Dr Stuart Schembri, until recently
consultant Physician in Respiratory and General Internal Medicine
at NHS Tayside. A submission of the full ECLS study findings is
being prepared for a leading peer-reviewed medical publication and
is expected to be published in Q3 2019.
Additionally, a late breaking abstract is being prepared for
presentation to The International Association for the Study of Lung
Cancer (IASLC) World Conference on Lung Cancer on 7-10 September
2019. The IASLC 2019 is the world's largest meeting dedicated to
lung cancer and other thoracic malignancies, hosting more than
7,000 delegates from more than 100 countries(3) .
The Company is also pleased to report that preparations are
underway in Scotland for the conduct of a phased population-based
evaluation to assess the implications of diagnosis with
EarlyCDT-Lung on survival and mortality in a real-world setting.
The initial phase is expected to recruit up to 200,000 patients,
each to be tested with EarlyCDT-Lung to be supplied by Oncimmune on
negotiated commercial terms.
Dr Adam M Hill, CEO of Oncimmune commented: "The final results
from the ECLS study, which I believe is the largest study of its
type ever undertaken for early lung cancer detection, represents
the culmination of over 16 years of research and development by
Oncimmune's scientists and our collaborators. I am particularly
excited about the potential now for scalable impact using
EarlyCDT-Lung in a cancer control evaluation in Scotland, expected
to commence later this year as well as the ripple effect of this
landmark study on lung screening programmes further afield."
Details of the ECLS Study
ECLS is a randomised controlled study of 12,210 participants in
areas of Scotland. Adults aged 50-75 who are at high risk of lung
cancer and healthy enough to undergo potentially curative therapy
(Performance Status 0-2) were eligible to participate. The
intervention is the EarlyCDT-Lung test, followed by X-ray and
computerised tomography (CT) scan in those with a positive test
result. The comparator is standard clinical practice in the UK. The
primary endpoint is the difference, at 24 months after
randomisation, between the rates of patients with stage III, IV or
unclassified lung cancer at diagnosis in the intervention arm and
those in the control arm. There are also a number of secondary
endpoints, details of which will be provided when the ECLS study is
fully reported.
-Ends-
For further information:
Oncimmune Holdings plc
Adam Hill, Chief Executive Officer
Matthew Hall, Chief Financial Officer
contact@oncimmune.co.uk
Zeus Capital Limited (Nominated Adviser and Joint Broker)
Andrew Jones, Mike Seabrook
+44 (0)20 3829 5000
Bryan, Garnier & Co Limited (Joint Broker)
Phil Walker, Dominic Wilson
+44 (0)20 7332 2500
Media enquiries:
FTI Consulting
Brett Pollard, Michael Trace, Alexander Davis
Oncimmune@fticonsulting.com
+44 (0)20 3727 1000
About Oncimmune
Beating cancer, one test at a time
Oncimmune is a leader in the development, manufacture and
commercialisation of cancer specific immunodiagnostics for the
screening, detection and care of cancer. Oncimmune also develops
precision medicine and patient stratification tools for leading
pharmaceutical multinationals in both immuno-oncology and
autoimmune disease. Oncimmune is working to change how cancer is
diagnosed and treated. Its patented technology detects evidence of
the body's natural response to cancer, enabling detection four
years or more before standard clinical diagnosis. Oncimmune's tests
facilitate clinical decision-making and are complementary to
diagnostic technologies, making them valuable additions to
established and new care pathways. Oncimmune partners with leading
developers and distributors to make our technology available
globally.
Oncimmune was founded in 2002 and launched its platform
technology in 2009, followed by its first commercial tests,
EarlyCDT-Lung and EarlyCDT(R) -Liver. To date, over 155,000 tests
have been performed for patients worldwide and EarlyCDT-Lung is
being used in what is believed to be the largest randomised
controlled study using biomarkers for the detection of lung cancer,
the National Health Service (NHS) ECLS study of 12,210 high-risk
smokers in Scotland. Oncimmune, headquartered at its laboratory
facility in Nottingham, UK, has a discovery research centre in
Dortmund, Germany and a CLIA lab in Kansas, US as well as an office
in London, UK and a partner representative office in Shanghai,
China. Oncimmune joined the Alternative Investment Market (AIM) of
the London Stock Exchange in May 2016 under the ticker ONC.L.
What is EarlyCDT-Lung?
A blood test using a panel of seven immunogenic proteins for the
testing of tumour-related antibodies specific to lung cancer.
For more information, visit www.oncimmune.com
(1) By number of participants
(2) Stage III or IV lung cancer
(3)
https://www.iaslc.org/events/iaslc-2019-world-conference-lung-cancer-wclc19
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END
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