Update on combined Clinical Trial Application

RNS Number : 4579M

Oxford Cannabinoid Tech.Holdings

12 January 2023

 

Oxford Cannabinoid Technologies Holdings plc

("OCTP" or the "Company")

Update on combined Clinical Trial Application for Phase I Clinical Trials

Further to the Company's announcement of 5 January 2023, OCTP confirms that the REC review meeting, an important element of the combined Clinical Trial Application for Phase I clinical trials for its lead programme OCT461201, took place yesterday. The ongoing review process is being undertaken in parallel by the Wales Research Ethics Committee ("REC") and the UK Medicines and Healthcare Products Regulatory Agency ("MHRA").

The Company will provide a further update on the outcome of the review in due course.

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 Kamran Hussain Richard Hutchison finnCap Ltd Geoff Nash/Fergus Sullivan Nigel Birks (ECM) Walbrook PR Limited Paul Vann/Nick Rome	[phone] [phone] [phone] [phone] [e-mail]

About Oxford Cannabinoid Technologies Holdings Plc:

Oxford Cannabinoid Technologies Holdings plc ("OCTP") is the holding company of 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 1 clinical trials, aimed at demonstrating safety and tolerability [in humans], due to commence in the near term. Trial results are expected in Q2 2023.   The global market for CIPN alone was valued at US$1.61bn in 2020 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 over 400 derivatives and intellectual property rights including 14 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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