Celadon Pharmaceuticals PLC Approval to roll-out chronic pain clinical trial (7869H)
August 01 2023 - 2:00AM
UK Regulatory
TIDMCEL
RNS Number : 7869H
Celadon Pharmaceuticals PLC
01 August 2023
Celadon Pharmaceuticals Plc
("Celadon" or the "Company")
Approval to roll-out chronic pain clinical trial
London, 1 August 2023 - Celadon Pharmaceuticals Plc (AIM: CEL),
a UK-based pharmaceutical company focused on the research,
cultivation, manufacturing and sale of breakthrough cannabis-based
medicines, announces that LVL Health, its private pain clinic, has
received approval from the National Health Service ("NHS") Research
Ethics Committee to roll-out its non-cancer chronic pain clinical
trial for up to 5,000 patients (the "Trial").
The Company previously held conditional approval from the
Medicines and Healthcare products Regulatory Agency ("MHRA") for
the Trial, however before formally commencing the Trial, the NHS's
Ethics Committee requested an initial Feasibility Study to be
conducted over a three-month period. The results of the Feasibility
Study were submitted for review on 30 December 2022 (as announced
by the Company) and indicated positive outcomes for quality of
life, pain and sleep, as well as the reduction of opioid usage.
As an approved Trial , it is believed to be the only one of its
kind in the UK, and is designed to create a data set that will
support doctors' prescriptions of cannabis-based medicines, and in
time enable potential reimbursement by the NHS and insurance
companies . It also enables G eneral Practitioners to prescribe the
medicine to patients in addition to specialist doctors, and
organisations such as charities can advertise recruitment for the
Trial. The Company believes this to be a major advance in enabling
much wider access for patients, ultimately leading to the opening
up of the UK market for cannabis-based medicines.
The Company is working with its partners to finalise the plan
for the optimal and timely roll-out of the Trial.
James Short, Chief Executive Officer of Celadon, said:
"We are delighted that our clinical trial has received its
approvals and we can now start the important work of getting our
medicine to patients. Everything we do at Celadon starts with the
patient, and the results from the first part of the study we have
seen in terms of improvements in quality of life have been
tremendous.
"Our longstanding aim remains to open up the UK market by giving
doctors confidence in prescribing and creating the most robust data
set to-date in the UK for cannabis-based medicines. This is why we
invested in LVL and the trial protocol in the first place, which
was over two years in development.
"This larger clinical trial was designed in collaboration with
the MHRA to provide a data set that will enable the potential for
prescription and reimbursement by the NHS and insurance
companies."
Enquiries:
Celadon Pharmaceuticals Plc
James Short Via Powerscourt
Arthur Wakeley
Jonathan Turner
Canaccord Genuity Limited (Nominated
Adviser and Broker)
Bobbie Hilliam / Andrew Potts / Patrick
Dolaghan +44 (0)20 7523 8000
Powerscourt Group
Sarah MacLeod / Nick Johnson / Sam Austrums
/
Ibrahim Khalil +44 (0)20 7250 1446
About Celadon Pharmaceuticals Plc
Celadon Pharmaceuticals Plc is a UK based pharmaceutical company
focused on the research, cultivation, manufacturing, and sale of
breakthrough cannabis-based medicines. Its primary focus is on
improving quality of life for chronic pain sufferers, as well as
exploring the potential of cannabis-based medicines for other
conditions such as autism. Its 100,000 sq. ft UK facility is EU-GMP
approved and comprises indoor hydroponic cultivation, proprietary
GMP extraction and manufacturing and an analytical and R&D
laboratory. Celadon's Home Office licence allows for the commercial
supply of its GMP pharmaceutical cannabis product. The Company's
subsidiary, LVL, owns a MHRA conditionally-approved clinical trial
using cannabis based medicinal products to treat chronic pain in
the UK. Celadon also has a minority interest in early-stage
biopharma Kingdom Therapeutics which is developing a licenced
cannabinoid medicine to treat children with Autism Spectrum
Disorder.
For further information please visit our website
www.celadonpharma.co.uk
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