For advocates of the under-explored therapeutic potential of cannabis, it’s a moment that’s been a long time coming. After years of controversy, uncertainty and confusion, it appears medical marijuana has finally begun to turn a corner in the eyes of the public and policymakers. Stances on cannabinoids – the chemical compounds found in cannabis – and their use vary widely, of course, but with huge markets like the US moving forward on a state-by-state basis with the legalisation of marijuana for medical and occasionally even recreational use, the window of opportunity has widened considerably in the last five years.
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And, just as schemes like Health Canada’s Marihuana for Medical Purposes Regulations (MMPR) bring the cannabis supply chain further into the realms of good manufacturing practice and the oversight of a fledgling commercial industry, it has become increasingly clear that a massive new investigational path for cannabinoid-based medicines has opened up.
It’s been known for some time that cannabinoids have therapeutic potential for a surprisingly wide range of conditions. Different cannabinoids – the most commonly known being tetrahydrocannabinol (THC) and cannabidiol (CBD) – have demonstrated anti-cancer, pain-relieving, anti-spasmodic and anti-inflammatory properties. British biopharma company and cannabinoid specialist GW Pharmaceuticals began supplying the world’s first fully approved cannabis-based drug, a mouth spray for multiple sclerosis called Sativex, in the UK from 2010, with approvals in other countries following thereafter.
The growing confidence in the medical marijuana industry was highlighted in August, when two Canadian medical marijuana producers, Bedrocan and Organigram, saw their shares soar within hours after listing on Canada’s TSX Venture Exchange. With firmer regulatory ground underfoot and a seemingly bright future ahead, the frequency of large-scale clinical trials of cannabis-derived therapies, and indeed the public demand for those trials, is starting to pick up.
GW Pharma to trial Epidiolex in New York State
A recent plan to initiate a clinical trial for epileptic children in the US state of New York is perhaps the most glaring demonstration of the shifting perceptions surrounding medical marijuana. In the US, where the legitimacy of medical marijuana was generating endless debate just a few years ago, it’s a startling leap forward to see an official agreement between New York State and GW Pharma, the British company behind Sativex, to trial a cannabinoid drug specifically for use by children with medication-resistant epilepsy. The fact that the trial agreement was largely prompted by the lobbying of parents with epileptic children – described as "very effective" by Republican New York Senate majority leader Dean Skelos – is a testament to the massive swing in the public’s outlook on medical marijuana.
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By GlobalDataGW Pharmaceuticals executive chairman Dr Geoffrey Guy on their cannabis-derived drug Sativex.
The agreement, which was announced in June 2014, will lead to the development of clinical trials for GW Pharma’s Epidiolex, a liquid formulation of purified CBD indicated for the treatment of several paediatric epilepsy syndromes, including Dravet and Lennox-Gastaut syndromes.
"Young New Yorkers battling these diseases deserve treatments that work for them, and by investigating the merits of cannabidiol we are pushing the boundaries of modern medicine and working to fundamentally improve the quality of life for those children," said New York Governor Andrew Cuomo. "I am very hopeful that this research collaboration will grow our understanding of these types of medications and ultimately help New Yorkers lead better lives."
New York is actually the second state, after Georgia, to initiate trials of Epidiolex, which also recently received Fast Track designation from the US Food and Drug Administration (FDA), granting the Epidiolex development programme extra access to FDA resources to accelerate the drug’s development and approvals process. GW Pharma has plans to initiate a Phase II/III clinical trial in Dravet syndrome later in 2014, with two Phase III trials in Lennox-Gastaut syndrome expected to follow in 2015.
In New York, the only real controversy surrounding the Epidiolex clinical trial agreement is that it won’t reach enough children. Critics have argued that the trial plan is a poor substitute for the Compassionate Care Act, an unpassed bill with bipartisan support that would legalise medical marijuana in New York. "Numerous scientific studies and in-depth medical research already show that when other medications fail, the safe use of medical marijuana is the last and only resort for patients crying out for relief," said New York State Senator Diane Savino, who sponsored the act in the State Senate. "Trials are all well and fine, but it’s time New York passes the Compassionate Care Act and get this signed into law."
Cannabis Technologies’ new drug design platform
Over the past few years, GW Pharma has done much to legitimise cannabinoid medicine as a promising pathway for developing new therapies, moving to the forefront of the field in the process. Now, more companies are following in their footsteps by moving into the development of novel, innovative therapeutics derived from cannabis. Vancouver-based Cannabis Technologies (CTI), which emerged in its current form in May 2014 after changing its name from Meridex Software and debuting on the Canadian Securities Exchange, is one such company. As Chris Parry of Stockhouse.com wrote in May: "Cannabis Technologies is looking to run off [GW Pharma’s] bow like a pilot fish tagging a Great White."
CTI is hitting the ground running with its proprietary Cannabinoid Drug Design Platform, a technology "designed to effectively identify and fast track new drug therapies", according to president and CEO Craig Schneider. The platform is intended to accelerate early-stage research and pre-clinical trials, allowing the company to reach the milestone of Phase I clinical trials in around 12-18 months.
CTI’s announcements over the summer appear to reinforce the effectiveness of its drug design platform. At the end of June, the company revealed it had already initiated Phase I clinical trials of its first therapy, a topical glaucoma treatment called CTI-085, after just 12 months of discovery and pre-clinical studies demonstrated its ability to reduce intraocular pressure in animal models. The formulation is a combination of cannabinoids and other active ingredients not derived from cannabis.
"The successful discovery and development of CTI-085 demonstrates to the market that our proprietary Cannabinoid Drug Design Platform can successfully identify treatments within our proposed target areas," said Schneider. We are looking forward to the continuation of expanding our product pipeline through the utilization of our Platform Technology." Indeed, less than two months later CTI announced that its second therapy, CTI-091, is in pre-clinical development for the relief of arthritic joint pain and swelling.
First trial under Health Canada’s new regulations
Pain relief is one of the original indications for medical marijuana, its use stretching back thousands of years. Evidence of its efficacy for easing the discomfort of conditions like arthritis is compelling but primarily anecdotal. Now that companies are operating on a surer regulatory footing concerning marijuana research in many countries, labs are beginning to turn their attention towards confirming the anecdotal evidence with hard scientific data.
A €53m project, launched under the EU’s Innovative Medicines Initiative, promises to accelerate trials of new Alzheimer’s treatments.
Such is the case for a new trial being carried out by Saskatoon, Canada-based medical marijuana producer CanniMed, the first clinical study to be approved since regulator Health Canada’s switch to the new MMPR rules for medical marijuana oversight. The randomised, double-blind, placebo-controlled study aims to assess the safety and efficacy of various doses of vaporised THC and CBD in adults with osteoarthritis of the knee. The basic science behind the benefit is the interaction between the cannabinoids contained within cannabis and receptors in the body’s own pain-regulating endocannabinoid system, which reportedly improve pain relief even in arthritis sufferers for whom the standard analgesics and anti-inflammatories aren’t enough.
"Medical cannabis has been used for more than 4,000 years by human beings, but we’ve never really put our minds and effort toward proper, disciplined scientific study," said CanniMed president and CEO Brent Zettl in an interview, as quoted by local Saskatoon paper The StarPhoenix. "We really want to look at the hard evidence that can hold up to scientific scrutiny."
"Well designed controlled trials are needed to answer many of the claims made around medical cannabis," added Dr Mark Ware, executive director of the Canadian Consortium for the Investigation of Cannabinoids, in a CanniMed press release. "Research of this kind will start answering some important questions about dose and efficacy, use of vapourization as a delivery system in clinical practice, and hopefully will encourage other licensed producers to join in the research endeavours."
The momentum Ware describes, the build-up of data as more producers and pharma companies put cannabinoids under the spotlight, is surely the way forward for medical marijuana and cannabis-derived treatments in a broader sense. The more familiar a thing becomes, the less scary it is, and the companies putting in the research work today are contributing to a clinical field that could, in the coming decades, improve health outcomes for millions of patients who might have otherwise run out of options.
