With the general prohibition on medicinal cannabis over the past 80 years, very little clinical research has been conducted.
Even in the USA, where states began legalising almost 2 decades ago, research institutes have found it challenging due to ongoing federal legislation.
When Australia legalised medicinal cannabis in 2016, this opened the door for companies to come and invest tens of millions of dollars on clinical research. Legalisation allowed companies to take advantage of Australia’s supportive research environment:
- Quick Human Research Ethics Committee approvals
- 48.5% R&D Tax Incentive
- Quality health system
- Data accepted by FDA, EMA, CFDA
- Much cheaper registration pathway
- Plenty of state and Federal grants
Here’s a rundown of some of the clinical research currently ongoing:
Palliative Care Phase II
- Bedrocan – Bedronal flos, vaporised (THC 13.5%; CBD <1.0%)
Led by Professor Meera Agar at the University of NSW, the trial started in 2016 with approximately 30 patients from Sacred Heart Health Service, St Vincent’s Hospital Sydney, and Calvary Mater Newcastle hospital.
The primary target of the trial is understanding how the product may provide relief to adult cancer patients in the final stages of life. Secondary targets include appetite, mood, and other factors.
Tuberous Sclerosis Complex Phase III
- GW Pharmaceutical – Epidiolex (synthetic CBD)
In 2016, GW Pharmaceuticals launched a global Phase III trial on Tuberous Sclerosis Complex (TSC), an illness in which epilepsy is present in over 90% of sufferers.
The study allows for 210 patients globally to access Epidiolex, to evaluate its use in treating seizures. Of these, 12 children are in NSW, participating through the Clinical Research Centre.
Chemo-Induced Nausea and Vomiting Phase II & III
- Tilray – 1:1 Capsule (THC 2.5mg; CBD 2.5 mg)*
Tilray has partnered with the NSW Government, the University of Sydney, and Chris O’Brien Lifehouse, researching the use of the capsule to provide relief from CINV symptoms in patients undergoing potent intravenous chemotherapy – “where standard treatments have proven ineffective.”
CINV occurs in up to 80% of chemotherapy patients and can have a significant impact on quality of life. For many patients, currently available drugs do not provide relief.
Glioblastoma multiforme Phase II
- 1:1 Oil (THC 6 mg/mL; CBD 6 mg/mL)
- 4:1 Oil (THC 15mg/mL; CBD 3.8mg/mL)
Bioceuticals has partnered with the Prince of Wales Hospital in Sydney, Dr Janet Schloss from Endeavour College of Natural Health and neurosurgeon Professor Charlie Teo to determine if medicinal cannabis can slow the growth of glioblastoma, a highly aggressive brain tumour.
The study is assessing two different ratio’s of THC and CBD, comparing them against similar patient groups at Professor Teo’s clinic within Prince of Wales Hospital.
The primary outcome is improving quality of life, with secondary outcomes being tumour response, absorption and pathology.
Tourette’s Syndrome Phase II
- BOD Australia – 1:1 Medicabilis oil (THC 5 mg/mL; CBD 5 mg/mL)
Sponsored and run by Wesley Medical Research, this study is primarily assessing mean tic severity in patients taking medicinal cannabis vs placebo.
Neuropsychiatrist Philip Mosley from Wesley Medical Research will trial Medicabilis in 24 adults with Tourette’s syndrome – a disorder which begins in childhood and is characterised by involuntary movements and vocalisations.
Dermatology – Varied
- Botanix Pharma – Synthetic CBD
Botanix is a clinical stage medical dermatology company based in Perth and Philadelphia. Their key active ingredient is synthetic CBD, who Mr Callahan strongly supports the use of, “the plant is the inspiration; it’s not necessarily the source of the material that you use in the drug.”
The company completed its first acne patient studies in January 2018, and commenced a Phase 2 study in June 2018 with completion expected mid-2019. The ongoing atopic dermatitis Phase 2 study is expected to be complete in the late 2019, and finally the Phase 1B psoriasis study should be completed by mid-2019.
Dementia/Alzheimer’s Phase II
- MGC Pharmaceuticals – CogniCann Oil (THC 25 mg/mL, CBD 17 mg/mL)
MGC Pharma is collaborating with University of Notre Dame Australia (UNDA) to assess the impact of medicinal cannabis on dementia and Alzheimer’s using their high THC oromucosal spray – CogniCann.
There are numerous trials at various stages of completion in throughout Australia, some of which are summarised below.
|Advanced Cancer – Quality of Life||Phase IV||Range of available products||NSW Government + UoN acting through the NHMRC Australian Centre for Clinical Cannabinoid Research Excellence (ACRE)|
|Advanced Cancer – Quality of Life||Phase II||1:1 CBD:THC||NHMRC + UQLD + Mater Misericordiae Hospital|
|Reduction in severe behavioural problems in youth with intellectual disabilities||Phase I/II||CBD||Murdoch Children’s Research Institute|
|Refractory Epilepsy||Phase II||20:1 CBD:THC||Cann Pharmaceutical|
|Epilepsy||Phase I||CBD||VIC Government + Neuroscience Trials Australia|
|Advanced Cancer – Palliative Care||Phase II||CBD||NHMRC + UQLD + Mater Misericordiae Hospital|
|Advanced Cancer – Palliative Care||Phase I||CBD vs THC||NHMRC + UQLD + Mater Misericordiae Hospital|
|Acne||Phase II||CBD||Botanix Pharmaceuticals|
|Stoma reversal post-operative Pain||Phase I||THC Flos vs Sativex||John Hunter Hospital + Hunter New England Local Health District|
|Tourette’s Syndrom||Phase II||1:1 CBD:THC||Wesley Medical Research Insititute|
|Acute non-traumatic low back pain||Phase II||CBD||Austin Medical Research Foundation + Dr Bronwyn Bebee|
|Insomnia||Phase II||Ratio unknown||Zelda Therapeutics|
|Pharmacokinetic, safety and tolerability||Phase O||NanoCelle CBD||Medlab Clinical|
|Intractable pain||Phase I||1:1 CBD:THC||Medlab Clinical|
|Glioblastoma multiforme||Phase II||1:1 vs 1:4 CBD:THC||BioCeuticals + Endeavour College of Natural Health|
|Anxiety||Phase II||CBD||The Lambert Initiative + Orygen|
|Chemo-induced nausea and vomiting||Phase II/III||1:1 CBD:THC||Tilray + NSW Health Administration Corporation|
|Cannabis and Mood Disorders in Adolescence||Phase II||CBD||National Cannabis Prevention and Information Centre + UNSW|
|Anorexia in Advanced Cancer||Phase I/II||High THC Flos||NSW Government|
|Cannabis and driving||Various vaporised||The Lambert Initiative + USYD|
|Cannabis and driving||Phase I/II||High THC vs Low THC||VIC Government + Swinburne Uni|
|Treatment-resistant cannabis dependance||Phase II/III||Sativex||National Health and Medical Research Council + USYD|
|Chemo-induced nausea and vomiting||Phase II||CBD||NSW Government + USYD|
|Management of cannabis withdrawal||Phase II||CBD||UNSW|
|Management of cannabis withdrawal||Phase II||Sativex||National Health and Medical Research Council + UNSW|
|Cannabis and driving||High THC Flos||Swinburne Uni + Securetec|
|Pain in kidney failure||Sativex||Northern Alberta Renal program|