TIDMORPH
RNS Number : 4074P
Open Orphan PLC
17 February 2021
Open Orphan plc
("Open Orphan" or the "Company")
Ethics Approval Granted for COV ID-19 Human Challenge Study
Model
Call for volunteers to enrol in studies that will play a key
part in developing effective vaccines and treatments for
COVID-19
Open Orphan plc (AIM: ORPH), a rapidly growing specialist
pharmaceutical services clinical research organisation (CRO) and
world leader in vaccine and antiviral testing using human challenge
clinical trials , announces the world's first COVID-19
characterisation study has received approval from a specially
convened Research Ethics Committee ("REC"). This news follows the
announcement on 20 October 2020 of Open Orphan subsidiary hVIVO's
contract with the UK Government to develop a COVID-19 human
challenge study model.
The initial virus characterisation study will inoculate up to 90
volunteers, between the ages of 18 and 30 years old, to enable
identification of the most appropriate dose of the virus needed to
cause COVID-19 (SARS-CoV-2) infection in a safe and controlled
environment. The study is set to commence shortly and is funded by
the UK Government. Imperial College London is the clinical study
sponsor and the study will be conducted by hVIVO at the Royal Free
London NHS Foundation Trust's specialist clinical research unit,
under the scrutiny of highly trained scientists and medics. The
virus being used in the characterisation study has been produced
under hVIVO's supervision by a team at Great Ormond Street Hospital
for Children NHS Foundation Trust in London, with support from
virologists at Imperial College London.
The REC approval completes all the independent external body
approvals required before the study can commence.
Individuals interested in taking part in this research can visit
www.UKCovidChallenge.com to learn more.
Chief Scientific Officer, hVIVO, Dr Andrew Catchpole, said:
"Ethical review of the research plan is a crucial part of
conducting clinical studies and approval from the Ethics Committee
represents a very important milestone in the development of the
COVID-19 challenge model. COVID-19 Human Challenge studies have the
potential to play an important role in providing data and
information that will help continue to develop vaccines to control
the pandemic.
"This study is a key enabling study to establish the COVID-19
challenge model and determine the lowest possible dose of virus
required. Data from this study will immediately facilitate the
challenge model to be used for vaccine efficacy testing as well as
to answer a wide range of fundamental scientific questions that are
not feasible with traditional field trials, such as exactly what
type of immunological response is required to confer protection
from re-infection."
Dr Chris Chiu, Clinical Reader, Honorary Consultant and Chief
Investigator of this study said: "The recent worsening of the
pandemic and urgent need to vaccinate people quickly and
effectively have raised new questions about COVID-19 and how to
best protect ourselves against it. This study will immediately tell
us about mild and asymptomatic infection, which is a major driver
of continuing transmission. While the first wave of vaccines are
being rolled out, human challenge studies could also be pivotal in
helping to shape the timings and doses of existing vaccines,
finding out how long one dose is protective for, and if they are
effective against new variants of the virus."
"The Research Ethics Committee has provided detailed independent
scrutiny. Their favourable opinion is a crucial step towards
getting this study open and running, and greatly helps us in our
efforts to minimise risks and enhance the quality of the
research."
Cathal Friel will be presenting at a Mello event on Monday, 22
February. To register for this, please follow the link:
https://melloevents.com/mellomonday-22nd-february-2021/
The information contained within this announcement is deemed by
the Company to constitute inside information as stipulated under
the Market Abuse Regulations (EU) No. 596/2014 ("MAR"). With the
publication of this announcement via a Regulatory Information
Service, this inside information is now considered to be in the
public domain.
For further information please contact:
Open Orphan plc +353 (0) 1 644 0007
Cathal Friel, Executive Chairman
Arden Partners plc (Nominated Adviser
and Joint Broker) +44 (0) 20 7614 5900
John Llewellyn-Lloyd / Benjamin Cryer
/ Dan Gee-Summons
finnCap plc (Joint Broker) +44 (0) 20 7220 0500
Geoff Nash / James Thompson/ Richard
Chambers
Davy (Euronext Growth Adviser and Joint
Broker) +353 (0) 1 679 6363
Anthony Farrell
Walbrook PR (Financial PR & +44 (0)20 7933 8780 or openorphan@walbrookpr.com
IR)
+44 (0)7876 741 001 / +44 (0)7980
Anna Dunphy / Paul McManus 541 893
Notes to Editors
Open Orphan plc
Open Orphan plc (London and Euronext: ORPH) is a rapidly growing
pharmaceutical service/contract research company that is a world
leader in testing vaccines and antivirals using human challenge
clinical trials. The company provides services to Big Pharma,
biotech and government/public health organisations.
Open Orphan runs challenge studies in London from both its
19-bedroom Whitechapel quarantine clinic, opened in February 2021,
and its 24-bedroom QMB clinic which also has a highly specialised
virology and immunology laboratory on-site. Open Orphan has a
leading portfolio of eight human challenge study models for
conditions such as RSV, flu, asthma and COPD. In addition, Open
Orphan is also developing the world's first COVID-19 human
challenge study model as part of the Human Challenge Programme and
has signed a reservation contract with the UK Government for the
first three COVID-19 vaccine challenge studies.
Building upon its many years of challenge studies and virology
research, the Company is developing an in-depth database of
infectious disease progression data. Based on the Company's Disease
in Motion(R) platform, this unique dataset includes clinical,
immunological, virological and digital (wearable) biomarkers. The
Disease in Motion platform has many potential applications across a
wide variety of end users including big technology, wearables,
pharma and biotech companies. Following COVID-19 there is now a
renewed interest and investment in infectious diseases.
Open Orphan's Paris office has been providing biometry, data
management and statistics to its many European pharmaceutical
clients for over 20 years. For over 15 years, the Company's
Netherlands office has been providing drug development consultancy
and services, including CMC (chemistry, manufacturing and
controls), PK and medical writing, to a broad range of European
clients. Both offices are now also fully integrated with the London
office and working on challenge study contracts as well as
supporting third party trial contracts.
Health Research Authority (HRA)
Before commencing a clinical study, researchers must submit an
application for Health Research Authority (HRA) approval which
brings together the assessment of governance and legal compliance,
with the independent Research Ethics Committee (REC) opinion to
confirm whether a research study has all the necessary approvals in
place from the relevant bodies to proceed. The HRA, as the body
responsible for running the UK Research Ethics Service, brought
together a group of experienced REC members from around the UK to
review the COVID-19 challenge study. The specially convened
committee was made up of 12 members, a mixture of lay people and
experts as required by law and has been recognised by UKECA (The
United Kingdom Ethics Committee Authority).
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