Oxford Cann Regulatory News (OCTP)

8 March 2022

Oxford Cannabinoid Technologies Holdings plc

("OCTP", or the "Company")

Data from pre-clinical study of OCT461201 shows positive results

Oxford Cannabinoid Technologies Holdings plc (LSE: OCTP, OTCQB: OCTHF), the pharmaceutical company developing prescription cannabinoid medicines targeting the US$ multi-billion pain market is pleased to announce positive results from a pre-clinical pain study for its lead compound, OCT461201, targeting the global Chemotherapy Induced Peripheral Neuropathy ("CIPN") treatment market valued at US$1.61bn in 2020 and forecasted to reach US$2.37bn by the year 2027.

CIPN is a peripheral neuropathy resulting from the neurotoxic effects of common chemotherapeutic drugs. The hallmarks of CIPN are pain, numbness and tingling in the extremities. On average, an estimated 60 per cent. of people undergoing chemotherapy are affected by CIPN at 3 months. CIPN can be progressive and enduring, leading to years of debilitation and suffering.

The results from OCTP's recent study show that OCT461201 successfully reduces pain in a pre-clinical animal model of CIPN induced by paclitaxel, a widely used chemotherapy agent. Two common symptoms of CIPN are pain caused by innocuous stimuli, like light touch (mechanical allodynia) and heat or cold (thermal hyperalgesia). In the study, OCT461201 significantly reduced pain from both mechanical allodynia and thermal hyperalgesia compared to untreated animals.

Globally, there is an urgent need for new therapies to treat CIPN as there are currently no approved therapies for this condition. The current standard of care is the off-label use of gabapentinoids (gabapentin and pregabalin) and antidepressants (e.g. duloxetine), drugs associated with serious side effects. Furthermore, in some cases their overall clinical effectiveness is inadequate, leaving cancer patients in pain, with a reduced quality of life and the prospect of having to change or stop their chemotherapy altogether.

Commenting on the results of the experiment, OCTP Chief Executive John Lucas said:

"To obtain such a positive result in this study is significant and provides further evidence that OCT461201 could be an effective therapy in the treatment of CIPN in cancer patients. Based on previously completed pre-clinical safety experiments, the Directors believe the administered dose of OCT461201 could have been increased by over three times. The results of this study demonstrate the opportunities open to OCT461201 in treating a major and common side effect experienced by so many cancer patients and we are more excited than ever to be starting phase 1 clinical trials early next year. These latest results reaffirm the potential of OCT461201 across multiple indications."

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.

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About Oxford Cannabinoid Technologies Holdings Plc:

Oxford Cannabinoid Technologies Holdings plc is the holding company of Oxford Cannabinoid Technologies Ltd, a pharmaceutical company developing prescription cannabinoid medicines for approval by key medicines regulatory agencies worldwide and targeting the U$ multi-billion pain market (together the "Group"). Cannabinoids are compounds found in the cannabis plant that have been shown to have a range of therapeutic effects on the body, including pain relief. The Group 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.

The Group's portfolio aims to balance risk, value and time to market, whilst ensuring market exclusivity around all its key activities. The Group's lead compound, OCT461201, is a highly potent and selective CB2 agonist and is being developed by OCT in a solid oral dosage form. OCT is conducting pre-clinical testing and development with clinical trials scheduled for Q1 2023. The Group's product pipeline also uses a balanced drug product strategy that employs both natural and synthetic compounds for the treatment of rare diseases and includes chemically modified phytocannabinoids with improved drug-like characteristics and a proprietary library of cannabinoids.

OCTP operates a partnership model with external academic and commercial partners. (https://www.oxcantech.com/)