Medicinal Cannabis Research in Australia – A Summary

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)*

* Note – the exact product has not been announced, rather the use of a capsule containing both THC and CBD, of which Tilray has one known product.

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

• Bioceuticals
  • 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.

Others

There are numerous trials at various stages of completion in throughout Australia, some of which are summarised below.