Oxford Cannabinoid Technologies (OCP) has reported promising results from studies testing the efficacy of its lead compound as a treatment for neuropathic pain.
The LSE-listed pharma firm’s OCT461201 compound is being tested in various “translational models” of both neuropathic and visceral pain.
Pre-clinical data has shown that it is well positioned for small fibre neuropathies, the firm reports, as it successfully reduced pain in a model of chemotherapy-induced peripheral neuropathy (CIPN).
In response to the data, the company says its strategy in neuropathic pain is to now focus on a clinical development programme aimed to benefit patients with small fibre neuropathies; such as cancer patients suffering from nerve damage caused by treatment with chemotherapy, and potentially, patients suffering from diabetic neuropathy.
There is an urgent need for new therapies to treat CIPN as there are currently no approved therapies for this condition.
The current standard of care is the off-label use of gabapentinoids and antidepressants drugs , which are associated with serious side effects.
Furthermore, in some cases their overall clinical effectiveness is inadequate, leaving cancer patients in pain, with a reduced quality of life and the prospect of having to change or stop their chemotherapy altogether.
The large unmet medical need in patients suffering from CIPN is estimated to have a global market valued at US$1.61bn in 2020 and forecast to reach US$2.37bn by the year 2027.
OCP believes this could grow to over US$7bn once combined with other small fibre neuropathies.
In addition to CIPN, the company will continue to develop OCT461201 for visceral pain in patients suffering from irritable bowel syndrome (IBS).
Another of its compounds, OCT130401, is a drug-device combination delivering phytocannabinoids to patients suffering from trigeminal neuralgia (TN) with a pressurised metered-dose inhaler.
TN causes debilitating and excruciating pain, has a fast and unexpected onset and is difficult to treat with conventional systemic medicines.
OCTP intends to undertake its phase one clinical trials in Q4 2022 involving healthy volunteers in Australia, to “benefit from the experience of local Human Research Ethical Committees, medical institutions, and clinical research organisations in supporting and performing clinical trials”.
The company is currently executing its due diligence process to select a partner contract research organisation to expedite the route to first in human trials.
In addition, it has entered into a five-year agreement with Benuvia Manufacturing Inc.
The company anticipates that it will shortly agree a Statement of Work with Benuvia for the manufacture of the drug-device combination for use in phase 1 clinical trials.
Patient groups are key to a thriving cannabis industry
Patient advocacy groups have called for more support from those in the cannabis industry.
It’s time the cannabis industry gave advocacy groups the support they deserve, argue campaigners, after all, they are the ones driving the sector forward.
Representatives from some of the UK and Europe’s leading cannabis advocacy groups have called for more support from those in the industry, highlighting the vital contribution they make to the development of the sector.
Speaking on a panel at Cannabis Europa in London on Wednesday 29 June, several leading campaigners said the industry had taken the efforts of patients for granted for too long.
In the words of Mary Biles, author and moderator of the event, it is the patients who “forged ahead and created this industry”.
It wasn’t the tireless efforts of CEOs which changed the law in November 2018, opening up a potentially highly profitable market – but also what many saw as an opportunity to make a “quick buck”.
It was the mothers and families, whose children were sick, who were full-time carers, surviving on just £62 a week from the government. It was the patients who put themselves at risk to educate others and call for change, despite their own limitations.
Jacqueline Poitras, founder of patient group MAMAKA and representative of the IACM Patient Council, is the campaigner responsible for changing the law in Greece, after fighting for her daughter to access medical cannabis.
“Our advocacy organisation started the ball rolling in 2016,” said Poitras.
“As in so many other countries, it was the patients who asked the politicians to change in law. What we have done ever since then is fill the role of everybody else who’s not in the value chain at the moment.”
The bridge between patients and industry
In the years since the law change, organisations such as Medcan Support and PLEA (Patient-Led Engagement for Access) in the UK, and the IACM Patient Council internationally, have become a vital bridge between the patients they support and the big businesses producing their medicine.
Medcan Support now has over 500 members, most of whom are parents and family members of children with severe epilepsy who are desperate for help and seeking advice, having heard that cannabis might help them.
PLEA has over 1,200 members and is run entirely by patients, all of whom are living with chronic conditions.
It is these organisations which take the lead on liaising with the private sector, lobbying for better standards for medical cannabis patients, educating clinicians and cannabis naive patients and even building the evidence base.
They are support workers, social media managers, campaigners, educators and consultants. And yet the majority, if not all, are volunteers.
“We all happened into this,” said Poitras.
“We were called to it and it’s not something that we can walk away from. If we don’t do it, nobody else is going to do it. We are convincing people and politicians that cannabis can help them. We are the bridge between companies and customers.”
She added: “But how much longer do I have to continue working at something on a volunteer basis?”
Representatives from PLEA revealed they work up to 40 hours a week behind the scenes, all for free. Its chairperson Lorna Bland has spent 40 years working in the voluntary sector having recently received a Royal Voluntary Service Award for the Platinum Jubilee.
Matt Hughes, co-founder of Medcan Support has a full-time job in IT, and a disabled son to care for. But he spends his evenings responding to questions from other families. He isn’t going to ignore them, he has been there himself after all.
On top of that him and his small team are organising and hosting webinars, creating social media content and acting as the vital go-between for private clinics and regulators.
“This is the core of what patient groups do, it’s not just social media and what people see from the outside, we’re usually the ones sorting out the issues in the private sector when the industry isn’t,” he told Cannabis Health.
“We do a huge amount that goes unnoticed, acting as a key link between patients and the industry. If a product is stopped leaving patients at risk of being left without medication, we are the ones sorting it out. If Medcan didn’t exist and we didn’t do all the work, who would?”
The value of lived-experience
When industry players do want to listen to the patients, they are usually expected to share their valuable insights and lived-experience for free.
“All of the information and experience that [advocacy groups] have gathered over the years, in the thousands of hours that have been invested into this and the patients around us, is valuable information for these companies,” said Poitras.
Co-founder of Medcan Support and director of Maple Tree Consultants, Hannah Deacon set up an initiative called Patients First with Volteface, earlier this year, which pays patients to participate in focus groups.
“What concerns me is that people see medical cannabis as a commodity and a way to make a quick buck,” she said.
“It’s not going to be sustainable. You need to listen to patients, because that’s how you develop a robust business.”
Deacon continued: “This is very personal. Businesses must not try to access this sort of information for free, because it’s very valuable and it’s a commercial thing that they are trying to achieve. If you are trying to do that, then you should help the people running those organisations. There are companies doing that, but not enough.”
Patients at the heart of everything
One company which is doing so is medical cannabis distributor, Chilam. Its co-founder and CEO, Monique Ellis, is a cannabis patient herself, having battled with endometriosis for over 20 years.
Chilam has put patients at the heart of its business strategy, investing in a comprehensive research and development programme before it’s even properly off the ground.
But Ellis doesn’t see this as a luxury, or a token gesture, rather a necessity that will set the company in good stead for the long haul.
“We’ve taken the view that the patient is at the absolute heart of everything we do,” said Ellis.
“It needs to be front and centre in your business model. It is sometimes described as a luxury to be able to roll out an R&D programme before you’re profitable or are trying to complete a funding round, but it’s not a luxury, it’s a must-have. You need to invest in it, it needs to be a core dimension to the business plan and you need to make those budget considerations.”
Ellis continued: “We need to make sure that we’re engaging with advocacy groups, and not just within the cannabis industry. We’ve got to think about cannabis naive patients that exist outside of the kind of small embryonic industry that we’re working with.
“That means that we need to give financial support to charities – it should be built into your social impact strategy. If these are not the values that are underpinning the way that you operate as a business, then you don’t have something that’s scalable and you won’t have patients for life.”
The key to developing the market
There are now said to be around 17,500 people with a legal prescription for cannabis in the UK. According to polls, 1.4 million people are self-medicating, suggesting the legal market has only fulfilled a tiny proportion of its potential.
There are just 110 doctors prescribing out of thousands on the specialist register who could legally do so.
Advocacy groups are the key to reaching those people.
“Keeping advocacy groups going is absolutely vital to this developing market,” said Deacon.
“I fear that we live in this bubble at the moment. The only way we’re going to reach the millions and millions of people in this country who could benefit, is by supporting advocacy groups who can get out and talk to naive patients, attend conferences and create education.
“Companies can’t do that, but we can and that’s why we are vital to the development of this sector. But we are volunteers and we cannot expand the work we do without being supported by the industry.”
The bottom line
We’re not talking about huge investments here. According to Deacon just £200 a month would allow Medcan Support to do more – and if 10 companies stumped up the cash, they could afford to employ someone to work full-time.
Poitras ended by urging cannabis businesses to reach out to patient groups in their country, she said: “Everything has to be built around this and if you’re not doing it at the moment, take a very critical look at your company and see where this can be placed within your system.”
Deacon added: “Every day that you go into the office, you need to think about who you’re working for. Who is your stakeholder?
“If you’re focused on your margins, then you’re not doing it for the right reasons. You need to be focused on who you serve, which is your patients and your doctors. I think when you start doing that, you’ll start winning.”
Khiron reports 65 per cent boost in revenue as it eyes up global expansion
Khiron has posted record 2022 Q1 numbers that included revenue of $4.6 million, a 65 per cent increase from Q1 2021.
Global medical cannabis company Khiron Life Sciences is continuing its expansion throughout Latin America and Europe as it grows its global network of medical cannabis treatment clinics.
Khiron has posted record 2022 Q1 numbers that included revenue of $4.6 million, a 65 per cent increase from Q1 2021, as well as record revenue in medical cannabis of over $2.6 million in Q1 2022, a 470 per cent increase from the prior year. Q1 2022 showed an operating cash outflow of 2.8 million against a total receivable of 4.4 million.
Khiron continues to grow with some of its newer operations already becoming profitable and EBITDA positive. Khiron says it is reducing expenses, selling high-margin products and taking a “disciplined” approach to its expansion.
Khiron is serving a record number of patients as it recently reached a cumulative stock of more than 100,000 bottles of medical cannabis sold. In countries such as Colombia and Germany, Khiron is benefiting from patients’ ability to utilise their health insurance for treatment in its medical cannabis clinics.
In the UK, Khiron has established market leadership with its first two products on the market. The company’s 20/1 THC-predominant strain is one of the best-selling medically prescribed products in the UK.
The wider European market poses an opportunity for Khiron as further countries beyond the UK are legalising medical cannabis. The company currently has its sights set on Germany, which has the potential to have over a million patients by 2024.
In Q1 2022, the UK and Germany represented 53 per cent of all medical cannabis revenue for the firm, compared to 10 per cent in Q1 2021.
The launch of a new product the THC-dominant full-spectrum extract KHIRIOX 25/1 is also on the horizon and will be available to pharmacies and patients in Germany and the UK in the near future. KHIRIOX 25/1 combines the medicinal properties of the established THC isolate formulations (dronabinol) with the specific advantages of a full-spectrum extract, which may have fewer side effects and be better tolerated by patients.
Khiron recently acquired Pharmadrug GmbH, which has provided Khiron with a European manufacturing and distribution centre for cannabinoid-based medicines. Keeping its wholesale fees in-house, the company expects the acquisition to have a direct positive impact on revenues and gross margins.
Headquartered in Bogata, Colombia, Khiron is also expanding its footprint in Latin America where it remains a market leader in medical cannabis, operating across Colombia, Peru, Mexico and Brazil.
With the election of a new pro-cannabis president, Gustavo Petro, Khiron foresees a positive environment for cannabis companies in Colombia. As the only country in Latin America with universal health insurance coverage for medical cannabis, over 82 per cent of Khiron sales were sold through insurance coverage and over 84 per cent of sales were sold to returning patients.
Sales of its products in Peru have grown more than 75 per cent from Q4 in 2021 to Q1 in 2022. Now, Khiron is launching its products in drugstores and pharmacies.
In March 2022, Khiron signed a partnership with Teleton pharmacies in Mexico, allowing it to establish its medical cannabis clinics within Teleton’s network across the country and distribute products in its pharmacies. Teleton has 24 Medical Centers including 22 rehabilitation centres, one autism centre and 1 Children’s Hospital for Cancer) located across the country, and around 600,000 patients with disability, cancer and autism conditions.
Brazil is the most recent market for Khiron’s Latin American expansion. Between late Q2 and early Q3 2022, Khiron will open its first clinic in Rio de Janeiro and expects to achieve its first import of high THC later in the year.
First export licence for medical cannabis approved in Isle of Man
The letter of approval will allow GrowLab Organics to cultivate, extract, manufacture, import and export medicinal cannabis.
The Isle of Man Government’s Department for Enterprise has confirmed that GrowLab Organics (GLO) has been offered the first conditional medicinal cannabis licence for export in the Isle of Man.
The Isle of Man Gambling Supervision Commission (GSC) has issued the first letter of approval in principle to GrowLab Organics to cultivate, extract, manufacture, import and export medicinal cannabis from the Isle of Man.
GLO is a British cannabis company founded in 2018 and headquartered in the Isle of Man. The company expects to create more than 50 jobs on the island within the next three years.
“The emerging cannabis sector is potentially the most exciting global development of this generation and has the capability to transform the quality of life for millions of people,” Alex Fray, Chief Executive Officer at GLO, commented. “GLO’s mission is to help people live better through the power of cannabis, whilst reducing the need for people to source cannabis from illicit sources for medicinal purposes. Our unique and innovative approach will improve the quality, consistency and range of products available to patients.
In early 2021 the Isle of Man Government introduced a regulatory framework to allow commercial operators to grow, manufacture, distribute and export cannabis products under licence from the Isle of Man. The initiative, which was supported by the Economic Recovery Group and Business Isle of Man, saw the Isle of Man Gambling Supervision Commission (GSC) appointed as the Regulator. Licence applications were opened in June.
The first licence has been issued conditionally and will enable the successful applicant to operate in the medicinal cannabis sector in the Isle of Man provided they meet the requirements outlined by the licence offer.
Minister for enterprise Tim Crookall said: “The Isle of Man has a rich history of innovation in developing new sectors, and our Department plan clearly sets out ambitious targets through the Business Agency to fully realise the potential of this market in the Island.
“This first offer letter represents the dawn of a new economic sector in the Isle of Man, which will drive high-value economic diversification across existing local sectors, stimulate job and training opportunities for Manx workers and encourage inward investment.
“I am optimistic that this will play a key part in the Isle of Man’s economic future and look forward to working with the Business Agency to continue to support and develop the highest calibre of companies establishing in the Island within the medicinal cannabis sector.”
The Isle of Man’s new medicinal cannabis industry is regulated by the GSC. Since applications opened last year, the organisation has worked closely with a wide range of stakeholders to develop and agree a licensing framework that will enable a well-regulated sector to grow on the island.
“Historically cannabis was woven into the fabric of Manx agriculture with hemp being grown on the island for rope and sail cloth,” Crookall added. “Now it’s back, with a continuation of the island’s history of innovation and economic diversity and as part of that we expect to create over 50 jobs within the next 3 years.”