CLINICAL TRIALS

Celadon is the majority shareholder of LVL Health, which has highly innovative Medicines and Healthcare products Regulatory Agency (MHRA) conditionally approved clinical trial in UK for chronic pain using cannabis-based medicines (CBMPs). 

A unique clinical trial

LVL’s CANPAIN trial is a Clinical Trial Investigating a Medicinal Product (CTIMP); this is slightly different from the typical three-phase clinical trial used for marketing authorisation, due to CBMPs being permitted under the UK Specials framework. LVL’s trial protocol was designed (and conditionally approved) in conjunction with UK regulators, such as the MHRA. 

The trial is designed to generate robust data that may enable re-imbursement on the National Health Service (NHS), as well as giving doctors more data to prescribe. 

Treating chronic pain

An estimated 8 million adults in the UK have moderate to severely disabling chronic pain. This covers a range of conditions, from fibromyalgia to musculoskeletal pain.

LVL’s study is designed to demonstrate the safety and efficacy of cannabinoids for chronic pain sufferers. This is more important than ever given the significant problems and side effects seen with opioid treatments in recent years. Moreover, it has been estimated that opioids only provide long term pain relief for 5-10% of patients1. In 2020, the UK’s National Institute for Health and Care Excellence (NICE) strongly advised against the use of opioids for chronic pain.

PRIMARY END POINT

pain levels

Secondary end points

quality of life, reduction in opioids, sleep improvement, back to work time

Stannard et al, (2016) Traditional opioids for chronic non-cancer pain: untidy, unsatisfactory, and probably unsuitable1

Trial milestones

LVL’s clinical trial is in two stages:

Initial study

Study commenced in September 2022, allowing for 100 patients

Main trial

Patient numbers may be scaled to up to 5,000 once LVL has approval from Research Ethics Committee (REC) to launch the scaled trial

Ground breaking medicine

The trial uses a leading inhalation device from Ryah, which is connected to a mobile app to collect patient data in real time and deliver a defined dost of medicinal cannabis at a pre-set temperature (to ensure the usage and dosage is as prescribed by doctors). The medicinal cannabis product inside the cartridge is high quality, consistent and made to GMP standards; patients have access to LVL’s specialist pain doctors and 24/7 clinic access.

LVL HEALTH

Promising early results

“Having been very active until two years ago, my condition caused me to be downcast and unhappy. Since starting the medication, I have reclaimed a large part of my life, being able to enjoy the outdoors again and re-gaining mobility. I am now happily walking up to an hour, walking dogs, swimming. Apart from the physical improvement, there has been a remarkable uplift of my mental wellbeing…It is just lovely to rediscover my sense of humour!

Annette 65 | Chronic Pain and Arthritis

“I can truly say that the medication has changed my day-to-day life in a big way. I’ve cut down by over 60% on my opioid painkillers. The medication works far better for my pain than the tablets ever did. It really works well for my joint pains, which has helped a lot with my mobility. Sleep is another great thing…Now I’m getting a steady eight hours a night.”

Derek 42 | Multiple Sclerosis

“I've suffered with neuropathic pain for 20+ years. I have tried almost every other treatment, medication and/or supplement under the sun. None of which gave much improvement and the pain I was in meant I was unable to work or, at its worst, even perform simple day to day tasks. For years I was left unable to focus on anything other than being in severe pain. Cannabis subdues most of these symptoms...As a result I've been able to live a much more fulfilled life, I've been able to contribute to family life (I have a wife and three kids), and for the first time in years I've even been looking for part time work. I've also been able to reduce taking the strong painkillers which I've relied on for years. Thank you all at LVL Clinic…for giving me a lot of my life back.”

David 48 | Complex Regional Pain Syndrome

“I had to stop work at 33 because the pain was too much. It’s been very depressing. For fibromyalgia, there isn’t anything, no magical pill. I was taking up to 40 tablets a day, including 14 prescriptions such as opiate painkillers, as well as sleeping pills and laxatives to relieve the constipation caused by the painkillers. With LVL’s medicine, straight away my sleep was a million times better. I probably hadn’t had a proper night’s sleep since 2012. My pain levels have completely dropped as well. I am now back at work at the National Grid. I wouldn’t be doing what I’m doing now if it wasn’t for medical cannabis. It’s been life changing.”

Andrea 39, Psoriatic Arthritis and Fibromyalgia

    How to register

    If you have non-cancer chronic pain and are interested in participating in LVL’s treatment programme

    APPLY HERE

     

    ENVIRONMENT

    Celadon uses a highly controlled indoor cultivation environment in order to produce plants to the tightest pharmaceutical tolerances and cannabinoid content. Hydroponics is used to grow plants in a soilless substrate, with mineral salts dissolved into high quality filtered water and delivered direct to the roots of the plant. Micro-zoned sensors monitor every aspect of the environment in real time; from the room’s temperature, lighting cycles and humidity, to the plant’s mineral absorption and transpiration rates. This allows Celadon to build a data bank of optimal growing conditions for each strain, as well as adjust the room automatically.

    TRACKING

    Celadon has a bespoke “track and trace” system throughout the production process, providing complete transparency. Each plant is given a unique QR code, allowing it to be traced from its origins through to the final product. IOT boxes are used to automatically feed data into the system, from environmental data to the product’s weight, at each stage of production. This provides full visibility over the production process, as well as inventory tracking and accurate cost analysis which feeds into our accounting systems.

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    Medical Cannabis Market, Transparency Market Research May 2022

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    Stannard et al, (2016) Traditional opioids for chronic non-cancer pain: untidy, unsatisfactory, and probably unsuitable

    This will close in 0 seconds

    Stannard et al, (2016) Traditional opioids for chronic non-cancer pain: untidy, unsatisfactory, and probably unsuitable

    This will close in 0 seconds

    Stannard et al, (2016) Traditional opioids for chronic non-cancer pain: untidy, unsatisfactory, and probably unsuitable

    This will close in 0 seconds

     

    ENVIRONMENT

    Celadon uses a highly controlled indoor cultivation environment in order to produce plants to the tightest pharmaceutical tolerances and cannabinoid content. Hydroponics is used to grow plants in a soilless substrate, with mineral salts dissolved into high quality filtered water and delivered direct to the roots of the plant. Micro-zoned sensors monitor every aspect of the environment in real time; from the room’s temperature, lighting cycles and humidity, to the plant’s mineral absorption and transpiration rates. This allows Celadon to build a data bank of optimal growing conditions for each strain, as well as adjust the room automatically.

    TRACKING

    Celadon has a bespoke “track and trace” system throughout the production process, providing complete transparency. Each plant is given a unique QR code, allowing it to be traced from its origins through to the final product. IOT boxes are used to automatically feed data into the system, from environmental data to the product’s weight, at each stage of production. This provides full visibility over the production process, as well as inventory tracking and accurate cost analysis which feeds into our accounting systems.

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    Legalised in 2018

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    Legalised in 37 States Limited Federal legalisation

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    Legalised in 2016

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    Legalised in 2016

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    Legalised in 2016 Rapid growth to >200k patients (2019-21)

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    Legalised in 2001

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    BUSINESS DESCRIPTION

     

    Celadon Pharmaceuticals Plc is a UK based pharmaceutical company focused on the research, cultivation, manufacturing, and sale of breakthrough cannabis-based medicines. Its primary focus is on improving quality of life for chronic pain sufferers, as well as exploring the potential of cannabis-based medicines for other conditions such as autism.

    Its 100,000 sq. ft UK facility operates to an EU-GMP standard and comprises indoor hydroponic cultivation, proprietary GMP extraction and manufacturing and an analytical and R&D laboratory. The Company's subsidiary, LVL, owns a MHRA conditionally-approved clinical trial using cannabis based medicinal products to treat chronic pain in the UK. Celadon also has a minority interest in early-stage biopharma Kingdom Therapeutics which is developing a licenced cannabinoid medicine to treat children with Autism Spectrum Disorder.

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    COUNTRY OF INCORPORATION/OPERATION

     

    Celadon Pharmaceuticals Plc is incorporated in England and Wales and is listed solely on the London Stock
    Exchange Alternative Investment Market (AIM), and is subject to the UK City Code on Takeovers and Mergers.

    TIDM: CEL.L
    ISIN: GB00BDQYGP38

    There are no restrictions on the transfer of Celadon Pharmaceutical’s shares.

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    AIM SECURITIES IN ISSUE

     

    The following information is correct as at 9th February 2023.

    The Company’s issued share capital comprises

    61,669,773 ordinary shares

    Each with a nominal value of 1 pence

    So far as the Company is aware, 69.8% of its issued share capital is not in public hands.

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