First Dose Administered & Pain Specialist Adviser

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 Clarissa Sowemimo-Coker (CEO) [phone] [e-mail]  Cairn Financial Advisers LLP Emily Staples Jo Turner [phone] [phone] Axis Capital Markets Limited Richard Hutchison Walbrook PR Limited Paul Vann/Nick Rome/Joe Walker [phone] [phone] [phone] [e-mail]

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.  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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