A GROUND-BREAKING human pilot study centred on the University of Manchester could provide answers to using cannabis as a pain relief treatment.
A minimum of 100 people are expected to be involved in the Flora Pharma backed research looking at the benefits of cannabinoids on patients with fibromyalgia, a long-term medical condition that causes widespread body pain and fatigue.
The ambitious pilot study is planned to run in parallel with molecular and pharmacokinetic work being undertaken in the US.
The work will be led by renowned cell and developmental biologist Dr Annabelle Manalo-Morgan, who is based at the Vanderbilt University in Nashville, Tennessee.
Developed CBD Formulation For Son
Dr Annabelle Manalo-Morgan turned her focus to alternative medicine and natural health consciousness, including clinical trial research in the medical cannabis space, after treating her son for epileptic seizures with her own CBD oil formulation.
She said: “I have always felt that in order to get cannabis more widely accepted on the legislative and medical level, we have to do studies in a traditional path with respected expert biologists.
“It’s been important to me to collaborate with scientists that are not actively working within the cannabis space because I felt like this is part of closing the gap and getting the non-believers on board.
“I’ve particularly been working closely with scientists in the UK for the past few years on the possibilities of this particular study. It took a ton of convincing to get the attention of this calibre of scientists but they are committed to filling the gaps in cannabinoid medicine.”
Patients on the human pilot study will be recruited using a fibromyalgia registry with the team at the University of Manchester responsible for the day-to-day data collection and reporting.
It is hoped when complete the research will back-up empirical evidence around the benefits of cannabis as an effective pain relief treatment.
New Division Of Flora Growth
Flora Pharma is a new a new division of US cannabis company Flora Growth which has been established to work on scientific clinical trials across the globe.
It is looking to fill scientific gaps with research to introduce data-backed pharmaceutical cannabis products with better efficacy and safety profiles than the traditional treatments.
Its president and CEO, Luis Merchan, told BusinessCann it made sense from a corporate standpoint and that ultimately it would create long-term value for patients globally.
He said: “We are making sure that a company that is a leader on a global scale is doing everything it can to support the claims that are being made about cannabis.
“From a commercial standpoint it makes a lot of sense as the more scientific based research we have the more claims we can make on the products available to consumers and patients.
“There is a lot of empirical evidence around cannabis. There is also a lot of stigma. Formal efforts made by the scientific community will ensure that the population broadly adopts cannabis as an alternative method, whether it is for wellness or for pharmaceutical types of medication.”
Mr Merchan added: “At Flora we believe that cannabis will be a solution for many wellness issues that are troubling humanity at this point. Some of them are pain, some of them are sleep, some are anxiety, to name a few, but there is not enough scientific-based research to support what we call today empirical claims from users – patients and consumers.
“This clinical trial with the University of Manchester is a step in the right direction to support one of these such elements, which is chronic pain, or fibromyalgia.”
Fibromyalgia has been specifically chosen because of the three areas of cannabis-related interest Flora is looking to explore: pain, sleep and anxiety.
Mr Merchan explained: “The three are very interesting in that there are a broad number of patients that are in need of support in one, two or all three of them. Fibromyalgia will allow us to identify the efficacy of these formulations because of the severity of the pain.”
He added it is intended to launch other medical trials in the near future to help support treatment for anxiety and sleep disorders.
When the human pilot study is approved, the control group will be split between those taking a placebo and test groups prescribed a number of formulations that have already been developed to determine their worth.
Peripheral research will also take place around related illnesses that could help identify other potential benefits for the formulations.
Mr Merchan said: “What we expect to come out of this trial are products and formulations that can, and will, go to market at a very rapid scale to support the treatment of these ailments.”
Determined Team Effort
The scientific efforts in the UK and US are being backed by additional work at organisations in Colombia, which is where the majority of Flora Growth’s operations are based. All of them are being led by Dr Manalo-Morgan, who lives in Nashville with her reggae artist and producer husband, Gramps Morgan.
She has been an advocate for cannabis since her now five-year-old son, Macario, began suffering up to 200 seizures a day. In desperation, doctors removed nearly 40% of his brain.
He was on seven medications a day, but rather than give in, Dr Manalo-Morgan took her son off all his prescribed medication and created a CBD oil compound for him to take, and he is now living a normal life.
Given her background, Dr Manalo-Morgan knew her experience would not be enough to convince the wider world of cannabis’ efficacy without hard evidence from clinical trials, and the data they provide.
Mr Merchan said setting up the Flora Pharma study has been a “determined effort from the Flora operational team, the team at the University of Manchester as well as Dr Annabelle and our chief revenue officer.
“They have been leading the efforts to ensure we are compliant and we are providing all the documentation that is needed. There are a number of players that are involved in an endeavour such as this, and all the credit goes to Dr Annabelle for taking the efforts to this stage where we are waiting for the ethics committee response.”
Part Of Company’s European Drive
The study coincides with Flora Growth making a concerted move on the European market.
The company recently bought a minority stake in European focused, fully integrated medical cannabis company Hoshi International, which has assets in both Portugal and Malta. It has also announced its intention to purchase Koch and Gsell, which under its consumer brand Heimat distributes a range of pure and blended hemp products, tobacco cigarettes, bulk flowers and tea to more than 2,500 stores across Switzerland as well as Belgium and Luxembourg.
Mr Merchan said: “That clearly signals our intention with regards to Europe. The launch of the clinical trials also shows that we would like to have the support of the scientific community on that side of the world to ensure that we continue to expand out network, our distribution and our reach.
“Europe is a very important market to us. We are keeping a close eye on Germany and what is happening there, with the election result, but we are also watching Italy, Spain, Portugal, the Netherlands and Malta amongst others as the regulatory environment is becoming more favourable.
“Flora is different from a lot of the companies in cannabis today in that we have not only a very robust wholesale operation where we have one of the lowest production costs of cannabis in the world at 6 cents per gram of dried flower, but we also have a very robust portfolio of products across multiple categories, whether it is topicals, supplements, medical devices, or food and beverage.”
He believes opportunities exist in the UK. “The regulatory environment is not clear, but that doesn’t mean that we are not going to be able to access it. I just think it is going to take a little longer than other countries in Europe.
“But we certainly feel it is a very attractive market. We have established distribution relationships, we have established our intentions to do scientific research there, and we have done so because we feel the market has a tremendous amount of potential.”
Trial Could Begin Within Weeks
The team behind the project say the human pilot study could begin within a matter of weeks – pending NHS Research Ethics Committee approval.
Flora Pharma hopes to fast track traditional NHS and American Food and Drug Administration (FDA) timelines by running in vitro, in vivo, human pilot and safety and efficacy phase trials in parallel.
Dr Manalo-Morgan told BusinessCann that the current protocol is in the final phase of review and will need the additional green light from the ethics committee.
She said: “However, we are using standardized FDA protocols and will follow patients once tracked treatment is complete. Our goal is to complete the study by the summer of 2022.”
Dr Manalo-Morgan added it would be “dependent on the milestones that we hit during the study. Of course, the sign-off on the ethics will be key, but typically there will be a team appointed to the study that will follow and provide feedback as we progress.
“Our ultimate goal is an NHS stamp of approval, so it is important to us to follow their guidelines and keep communication tight.”
Once ethics committee approval has hopefully been granted, Dr Manalo-Morgan said further details about the research and the University of Manchester team would be made public.