Oxford Cannabinoid Tech.Holdings Phase I Clinical Trial Results (4789P)
10 Octobre 2023 - 8:00AM
UK Regulatory
TIDMOCTP
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:
O xford 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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