TIDMORPH
RNS Number : 9130H
Open Orphan PLC
09 August 2021
9 August 2021
Open Orphan plc
("Open Orphan" or the "Company")
Development of Controlled Human Malaria Infection Human
Challenge Study
hVIVO to assist in the advancement of antimalarial drug and
vaccine candidates from November 2021
Open Orphan plc (AIM: ORPH), a rapidly growing specialist
clinical research organisation (CRO) and world leader in testing
vaccines and antivirals using human challenge clinical trials,
announces that its subsidiary, hVIVO , has developed a Controlled
Human Malaria Infection ("CHMI") challenge model , both
strengthening and further diversifying the Company's world leading
portfolio of viral challenge study models. The Malaria challenge
model will assist in the advancement of antimalarial drug and
vaccine candidates from November 2021. Results from CHMI modelling
of drug and vaccine efficacy have previously shown good translation
into the field.
Malaria is a serious and life-threatening disease prevalent
across much of tropical and sub-tropical Asia, South America and
Sub-Saharan Africa. Due to increasing resistance to current
antimalarial regimens, new drugs are required as both stand-alone
and partner therapies to address a growing unmet medical need. In
addition, novel combinations of existing drugs may be required to
fill the gap until pipeline candidates can be safely progressed to
market. New drugs and combination therapies are required to not
only reduce mortality and morbidity in susceptible, primarily
paediatric populations, but also to help the move towards a greater
goal of malaria elimination.
hVIVO has secured access to a unique, GMP-manufactured P.
falciparum sporozoite challenge agent ("PfSPZ Challenge") for use
in its malaria challenge studies. PfSPZ Challenge has been used in
multiple clinical trials in the United Kingdom, United States,
Europe, Indonesia and Africa. As of June 2021, 1,204 volunteers
have received 2,011 doses of PfSPZ Challenge (NF54) with no
unresolved serious adverse event, sequelae, or deaths to date.
Controlled Human Malaria Infection by Direct Venous Inoculation has
largely replaced the traditional method of CHMI (mosquito bite),
owing to its superior predictability and safety profile. Reported
symptoms are mostly mild to moderate and include headache, fever,
nausea and fatigue.
Cathal Friel, Executive Chairman of Open Orphan, said: "Malaria
is a disease of huge unmet need around the world, with 229 million
cases and 409,000 deaths caused in 2019. Its prevention and cure is
a designated World Health Organization target. We are pleased to
have formally announced today the latest addition to our portfolio
of human challenge models namely the Malaria Human Challenge Study
Model. The safety profile of PfSPZ is impressive, and we are
optimistic that it will enable us to assist in the advancement of
antimalarial drug and vaccine candidates from November. This also
adds a new challenge model to our already world leading portfolio
of viral challenge study models and continues to build on our
global infectious disease expertise. "
Interested in becoming a volunteer?
hVIVO recruits many of its volunteers for its challenge study
clinical trials through its dedicated volunteer recruitment
website, www.flucamp.com . By volunteering to take part in one of
our studies in a safe, controlled, clinical environment under
expertly supervised conditions you are playing your part to further
medical research and help increase the understanding of respiratory
illnesses.
Individuals interested in taking part in COVID-19 human
challenge study research can learn more at www.UKCovidChallenge.com
.
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 / Louisa Waddell / Oscair
McGrath
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)
Paul McManus / Louis Ashe-Jepson +44 (0)7980 541 893 / 07747 515 393
/ Sam Allen / 07502 558 258
Notes to Editors
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 with its highly specialised on-site
virology and immunology laboratory. Open Orphan has a leading
portfolio of human challenge study models for infectious and
respiratory diseases and is developing a number of other models
including the world's first COVID-19 human challenge study model as
part of the Human Challenge Programme .
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 .
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