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REG - Oxford Cannabinoid - First Dose Administered & Pain Specialist Adviser

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RNS Number : 3123H  Oxford Cannabinoid Tech.Holdings  27 July 2023

 

 

27 July 2023

Oxford Cannabinoid Technologies Holdings plc

("OCTP" or the "Company")

 

First Dose Administered in Phase I Clinical Trial for Lead Drug Candidate
OCT461201

 

&

 

Appointment of internationally recognised Pain Specialist Dr Farquhar-Smith

 

OCTP is delighted to announce that the first-in-human dose of its lead
pharmaceutical drug compound, OCT461201, has been successfully administered,
as part of its Phase I clinical trial.

 

The trial is being conducted in the UK in healthy volunteers by Simbec
Research Limited, part of Simbec-Orion Group Ltd, using a single ascending
dose protocol. The trial's principal objective is to demonstrate the safety
and tolerability of OCT461201, whilst also providing pivotal information on
its pharmacokinetic profile, to confirm its value as a potential drug.

 

Results from the trial, which is being funded entirely from OCTP's existing
resources, are expected in Q3 2023.

 

Senior Advisory Appointment

OCTP is also very pleased to announce a further strengthening of its advisory
team with the appointment of Dr William Paul Farquhar-Smith, an
internationally recognised expert in Chemotherapy-Induced Peripheral
Neuropathy ("CIPN"), as an external adviser to the Company.

 

CIPN is a painful and disabling condition that occurs as a side effect of
certain chemotherapy drugs. The global CIPN market is currently valued at
US$1.61bn. OCTP's lead compound, OCT461201, now in Phase I clinical trials,
has preclinical data indicating a successful reduction in CIPN induced pain.

Dr Farquhar-Smith is a Consultant in Pain Medicine and Anaesthetics at The
Royal Marsden Foundation NHS Trust where he leads the only dedicated CIPN
clinic in the UK. He holds fellowships from both the Faculty of Pain of the
Royal College of Anaesthetics and the Faculty of Intensive Care Medicine. His
special interests include pain experienced by cancer patients, anaesthesia and
pain education.

 

Dr Farquhar-Smith has also contributed to reference textbooks, authored
guidelines for cancer pain management published by the British Pain Society,
where he is co-chair, and lectured both nationally and internationally, whilst
maintaining an active research portfolio. He is a reviewer for Cochrane and
has advised on policy including NICE guidelines. He has, to date, published
over 80 peer-reviewed original articles, chapters and letters.

 

Dr Farquhar-Smith currently sits on the Editorial Board of the British Journal
of Pain, is co-chair of the Association of Palliative Medicine joint working
group in Pain in Cancer Patients, serves as Editor of Cancer Pain in Current
Opinion in Supportive and Palliative Care Journal, whilst also being section
Head for Chronic Pain for the f1000 educational website.

On the Clinical Trial, Clarissa Sowemimo-Coker, Chief Executive Officer of
OCTP commented: "I am so pleased and proud to be able to announce the first
dose of OCT461201 being administered to a healthy volunteer. Both symbolically
and commercially, this is an enormous milestone for OCTP. Whilst this is the
culmination of years of hard work, it also lays down a marker for the future
and signals the beginning of a bigger journey."

On the appointment of Dr Farquhar-Smith, Ms Sowemimo-Coker added: "We are
delighted to welcome Dr Farquhar-Smith as an adviser to OCTP. His clinical
expertise and deep knowledge of CIPN will be of exceptional value to us as we
move forward with our clinical trials for OCT461201, which we hope will prove
to be a first-in-class treatment.

"On average, an estimated 60% of people undergoing chemotherapy are affected
by CIPN after three months often resulting in patients reducing or ceasing
treatment as a result. Considering that the global market for CIPN alone is
forecast to reach $2.37bn by 2027 it is clear that there is both a significant
market opportunity and potential to improve people's lives."

 

This announcement contains inside information for the purposes of Article 7 of
EU Regulation 596/2014 (which forms part of domestic UK law pursuant to the
European Union (Withdrawal) Act 2018).

 

The Directors of the Company accept responsibility for the content of this
announcement.

 

 

  Enquiries:

Oxford Cannabinoid Technologies Holdings plc  +44 (0)20 3034 2820

 Clarissa Sowemimo-Coker (CEO)                 clarissa@oxcantech.com

 Cairn Financial Advisers LLP

 Emily Staples                                 +44 (0)20 7213 0897

 Jo Turner                                     +44 (0) 20 7213 0885

 Axis Capital Markets Limited

 Richard Hutchison                             +44 (0)20 3026 0320

 Walbrook PR Limited

 Paul Vann/Nick Rome/Joe Walker                +44 (0)20 7933 8780

                                               +44 (0)7768 807631

                                               oxcantech@walbrookpr.com

About Oxford Cannabinoid Technologies Holdings Plc:

Oxford Cannabinoid Technologies Holdings plc ("OCTP") is the holding company
of Oxford Cannabinoid Technologies Ltd (together the "Group"), a
pharmaceutical Group developing prescription cannabinoid medicines targeting
the U$ multi-billion global pain market.

 

OCTP currently has a portfolio of four drug development programmes. Its lead
compound, OCT461201, will initially target neuropathic and visceral pain
(including irritable bowel syndrome ("IBS") and chemotherapy induced
peripheral neuropathy ("CIPN")), with Phase I clinical trials, aimed at
demonstrating safety and tolerability. Trial results are expected in Q3
2023.
(https://www.londonstockexchange.com/news-article/OCTP/updates-on-lead-programme-1-and-programme-2/15391762)
The global market for CIPN alone is currently valued at US$1.61bn and is
forecast to reach US$2.37bn by the year 2027.

 

OCTP's drug development pipeline comprises both natural and synthetic
compounds, and includes compounds targeting trigeminal neuralgia, a severe
type of face pain, and cannabinoid derivatives targeting pain and potentially
other therapeutic areas. Having established an exclusive license agreement
with Canopy Growth Corporation for their entire pharmaceutical cannabinoid
derivative library, OCTP now has a portfolio of almost five hundred
derivatives and intellectual property rights including fourteen patent
families and associated research data.

 

OCTP has a clearly defined path to commercialisation, revenues and growth. The
Group is developing drug candidates through clinical trials to gain regulatory
approval (FDA/MHRA/EMA) that will enable medical professionals to prescribe
them with confidence. OCTP's portfolio aims to balance risk, value and time to
market, whilst ensuring market exclusivity around all its key activities.

 

Caution regarding forward looking statements

Certain statements in this announcement, are, or may be deemed to be, forward
looking statements. Forward looking statements are identified by their use of
terms and phrases such as ''believe'', ''could'', "should" ''envisage'',
''estimate'', ''intend'', ''may'', ''plan'', ''potentially'', "expect",
''will'' or the negative of those, variations or comparable expressions,
including references to assumptions. These forward-looking statements are not
based on historical facts but rather on the Directors' current expectations
and assumptions regarding the Company's future growth, results of operations,
performance, future capital and other expenditures (including the amount,
nature and sources of funding thereof), competitive advantages, business
prospects and opportunities. Such forward looking statements reflect the
Directors' current beliefs and assumptions and are based on information
currently available to the Directors.

 

 

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