REG - Oxford Cannabinoid - Appointment of Phase I Clinical Trial CRO

Oxford Cannabinoid Technologies HoldingsAnnouncement

11/04/2024 11:30

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RNS Number : 2989K  Oxford Cannabinoid Tech.Holdings  11 April 2024

 

Oxford Cannabinoid Technologies Holdings plc

("OCT" or the "Company")

 

Appointment of Phase I Clinical Trial CRO

&

Change of Accounting Reference Date

Oxford Cannabinoid Technologies Holdings plc (LSE:OCTP), a clinical stage
biopharmaceutical company focused on the development and commercialisation of
innovative cannabinoid medicines, today announces that, through its
subsidiary, OCT Victoria Pty Ltd, it has entered into agreement with iNGENū
CRO Pty Ltd (iNGENū), to conduct a Phase I randomised, double-blind,
placebo-controlled dose escalation study to evaluate the safety, tolerability
and pharmacokinetics of OCT130401.

iNGENū is an Australia-based, globally focused contract research organisation
(CRO) possessing extensive experience working in the cannabinoid
pharmaceutical drug development and clinical research industry. The
appointment follows a meticulous vendor selection process, which included a
detailed competency-based assessment of prospective CROs' credentials, of
their cost-effectiveness and of appropriate regulatory pathways.

OCT130401 is a combination of synthetic phytocannabinoids (pCBs) and a medical
device for the effective, safe, and non-addictive treatment of chronic and
severe pain conditions. The initial target for OCT130401 is trigeminal
neuralgia (TN), which is a chronic pain condition that causes an excruciating,
stabbing, electric shock-like facial pain. TN has a fast and unexpected onset,
making it difficult to treat and each episode may last only a few seconds, but
some people will suffer multiple (up to 100) episodes during a single day.

Clarissa Sowemimo-Coker, Chief Executive Officer of OCT, said:

"I am pleased to announce that OCT has selected iNGENū as its CRO partner for
our Phase I clinical trial for our second programme, OCT130401, targeting
Trigeminal Neuralgia. iNGENū is a well-recognised CRO, with a specific
expertise in cannabinoids and the Australia regime also affords a direct path
to US FDA approval which is an important target for the Company. Today's
appointment and our confirmation that clinical trials will begin in Q2 2024
demonstrate that OCT continues to hit its milestones and is making good
progress."

Dr Sud Agarwal, Chief Executive Officer of iNGENū, said:

"We are delighted to be OCT's CRO partner in its first Australia-based
clinical trial. Whilst many people are aware of the financial benefits of the
Australian research regime, many are less aware of the world-class clinical
research units and the favourable regulatory laws, allowing rapid study
start-up. We look forward to kicking off this work, which is aiming to meet a
significant unmet need for people living with Trigeminal Neuralgia."

Change of accounting reference date

In order to align the Group's accounting period with that of its Australian
subsidiary, OCT Victoria Pty Ltd, OCT and its UK subsidiary, Oxford
Cannabinoid Technologies Ltd, will amend their accounting reference date and
financial year-end from 30 April to 30 June, with immediate effect. This
change will generate reporting efficiencies and provide for direct
comparability of the Group's reporting across future periods.

As a result of this change, the Group's next financial reporting events will
be as follows:

  ● Publication of audited accounts for the fourteen months ended 30 June
2024 by 31 October 2024; and

 ● Publication of unaudited interim accounts for the six months ended 31
December 2024 by 31 March 2025.

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 (mailto:clarissa@oxcantech.com)

 Hybridan LLP, Financial Adviser and Lead Broker
 Claire Louise Noyce                              +44 (0)20 3764 2341

 Axis Capital Markets Limited, Broker
 Richard Hutchison                                +44 (0)20 3026 0320

 Acuitas Communications, Financial PR             020 3745 0293 / 07799 767676
 Simon Nayyar                                     simon.nayyar@acuitascomms.com
 Arthur Dingemans                                 arthur.dingemans@acuitascomms.com

 

About Oxford Cannabinoid Technologies Holdings Plc:

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

 

OCT 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 chemotherapyinduced peripheral
neuropathy ("CIPN"). The global market for CIPN alone is currently forecast
to reach US$1.17bn by 2028.

 

OCT'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 licence 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.

 

OCT 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. OCT's portfolio aims to balance risk, value and time to
market, whilst ensuring market exclusivity around all its key activities.

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