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RNS Number : 4789P Oxford Cannabinoid Tech.Holdings 10 October 2023
Oxford Cannabinoid Technologies Holdings plc
("OCTP" or the "Company")
Phase I Clinical Trial Results for Lead Drug Candidate OCT461201
Oxford Cannabinoid Technologies Holdings plc (LSE: OCTP), the pharmaceutical
company developing prescription cannabinoid medicines, is pleased to announce
that dosing of all the cohorts of the Phase I, single ascending dose study for
OCT461201 has been successfully completed. No safety or tolerability concerns
were exhibited with any dose tested. As a result, OCTP is satisfied that it is
safe to proceed to the next stage of clinical development of its lead compound
OCT461201.
The trial was conducted in the UK in healthy volunteers by Simbec Research
Limited, part of Simbec-Orion Group Ltd, using a single ascending dose
protocol. The final dose was administered on 20 September 2023, followed by
formal review of final clinical data on 2 October 2023. The trial's primary
objective was to demonstrate the safety and tolerability of OCT461201, whilst
also providing important information on its pharmacokinetic profile.
Clarissa Sowemimo-Coker, Chief Executive of OCTP, said:
"I am delighted to announce the completion of our Phase I, single ascending
dose study of our lead drug candidate, OCT461201. This is a significant
milestone in OCTP's journey as we cement our transition into a clinical-stage
business. Today's announcement represents the culmination of many years of
hard work by our team, in particular from our Chief Scientific Officer, Dr
Valentino Parravicini, and Chief Medical Officer, Dr Tim Corn, whose diligence
and expertise have brought us to this point fewer than 30 months since
flotation. We look forward to moving OCT461201 into the next phases of its
development".
Dr Tim Corn, Chief Medical Officer of OCTP, said:
"This announcement marks an important milestone in the clinical development of
OCT461201. We are very pleased to have completed this stage in the development
of our lead candidate. To have reached this point within this timeframe is a
noteworthy achievement and one which we are well positioned to build upon."
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
Acuitas Communications 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 ("OCTP") is the holding company
of Oxford Cannabinoid Technologies Ltd (together the "Group"), a
pharmaceutical Group developing prescription cannabinoid medicines initially
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. The global market for CIPN alone is
currently forecast to reach US$1.17bn by 2028.
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.
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