Research being conducted on the safety and efficacy of MediCabilis™
Bod is in collaboration with various research institutes to investigate the safety and efficacy of our MediCabilis™ pharmaceutical-grade medicinal cannabis.
Clinical Studies Currently Open For Recruitment
Project Twenty21 – UK
Project Twenty21 aims to create the largest body of evidence for the efficacy of medicinal cannabis in the UK. The initiative will use collated data to support policy makers as they review medicinal cannabis availability, and affordability for patients who would benefit from its use. The project will assist prescribers operating in private practice and advance the potential for UK Government Health (NHS) funding. Project Twenty21 will focus on the following conditions:
- Anxiety Disorder
- Chronic Pain
- Multiple Sclerosis (MS)
- Post-Traumatic Stress Disorder (PTSD)
- Substance Use Disorder (as a harm reduction strategy)
- Tourette’s Syndrome
MediCabilis ™ is included in this landmark study with Bod as the only Australian company participating in Project Twenty21. If you are in the UK and have patients who would like to register their interest or require more information, please have patients complete the online form.
Updates to Project Twenty21:
Project Twenty21 – Costs and Progress (9 July 2020)
Observational Study On MediCabilis™ – Australia
Bod is currently conducting Bod Open-Label Observational Study (BodOLOS) (ACTRN registration no: ACTRN12620000741987), which is an Australia-wide observational study that aims to assess the safety, tolerability and efficacy of Bod’s pharmaceutical MediCabilis™ in patients undergoing medicinal cannabis therapy for any indication
Patients who are prescribed MediCabilis™, with the approval of the Therapeutic Goods Administration (TGA’s), may be invited to participate in this important observational study. More information on how to participate in the observational study can be found here.
Clinical Trial For Insomnia (Phase 1 / Phase 2) – Australia
A pilot study investigating the efficacy of one of Bod’s medicinal cannabis product for its potential in treating insomnia in a landmark sleep study is being conducted at the Woolcock Institute of Medical Research, under direction from Professor Ron Grunstein, in partnership with the Lambert Initiative.
Patients who would like to participate can email the trial coordinator (Anastasia) on email@example.com or check their eligibility at: http://www.cansleepstudy.com.
Clinical Trial For Motor Neurone Disease (Phase 3) – Australia
A landmark clinical study is taking place in 2020 to investigate if the MediCabilis™ 5% CBD (LINNEA 315CSE™) full-spectrum oil can help patients with Motor Neurone Disease (MND), also referred to as Amyotrophic lateral sclerosis (ALS). This will be the first study to examine if medical cannabis can not only improve the symptoms associated with MND but also slow or halt the progression of the disease.
The study is a single-centre clinical trial taking place at the Gold Coast University Hospital and being led by neurologist Dr Arman Sabet. It is a double-blind, randomised and placebo-controlled study with half of the study participants receiving medicinal cannabis for at least 6 months. More information on the study can be found here or through contacting study coordinator Mr Berzenn Urbi, Berzenn.Urbi@health.qld.gov.au.
Clinical trial for Tourette’s syndrome (Phase 2) – Australia
Bod’s medicinal cannabis product is being investigated as a potential treatment option for Tourette’s syndrome. The study is being conducted by the Wesley Medical Research in Brisbane, with the support of the Lambert Initiative for Cannabinoid Therapeutics at the University of Sydney.
Patients can find more information on the study or register their interest to participate here.
Other Studies and Published Research
Phase 1 Clinical Trial
Bod Australia has invested in a phase 1 clinical study that assessed the safety, tolerability and pharmacokinetics of the MediCabilis™ 5% CBD (LINNEA 315CSE™) full-spectrum oil and innovation wafer delivery technology. The research was conducted and complete at Nucleus Network, Australia’s leading clinical research organization for Early Phase Clinical Trials.
Bod has also entered a collaboration with researchers from the University of South Australia (UniSA) to further expand research of its MediCabilis™ 5% CBD (LINNEA 315CSE™).
As part of this collaboration, Bod and UniSA will conduct research into MediCabilis and its effects on consumers. The studies will assist in ongoing product development, as well as provide valuable information for clinical practice, future research and any additional trials that Bod may pursue in the future.
The collaboration will be undertaken with researchers that are part of UniSA’s School of Pharmacy and Medical Sciences. The department is nationally renowned and brings together internationally recognised health research concentrations in the quality use of medicines, drug development and pharmaceutical science.
his collaboration will lay a strong foundation for future research initiatives associated with the product and its specific exclusive extract. Further, it will minimise any risks associated with future research and assist in study design.
Bod has been in collaboration with University of Technology Sydney, who have discovered a novel family of proteins found in human cells that provide antioxidant protective effects when applied to cells. Bod is of the view that these could be used topically to combat the skin ageing process.
The proteins were found to be instrumental in protecting cells and increasing tolerance and recovery from UV light. Laboratory testing also showed increased levels of antioxidant activity, cellular growth and metabolism, furthering the protein’s cellular protective effects.
Bod will now pursue the development of a patent protected, novel anti-ageing topical application and topical delivery system. The Company retains the global rights to the delivery method, which it will commercialise or licence to a large healthcare or pharmaceutical company. Bod and UTS will continue to explore potential uses for the protein in collaboration with CBD and hemp products, as well as other cannabis compounds.
Anti-inflammatory Effect of LINNEA 315CSE™ in human immune cell model
A team led by Professor Marco Cosentino, from the University of Insubria, Italy, conducted a study showing the MediCabilis 5% CBD full-spectrum oil had anti-inflammatory efficacy in a human immune cell model (polymorphonuclear leukocytes). They also determined that the full-spectrum extract was more efficacious than CBD alone, suggesting the other constituents of the extract are enhancing CBD’s therapeutic benefit.
Mabou Tagne A, et al. A Novel Standardized Cannabis sativa L. Extract and Its Constituent Cannabidiol Inhibit Human Polymorphonuclear Leukocyte Functions. Int J Mol Sci. 2019; 20(8). DOI: https://doi.org/10.3390/ijms20081833
Anti-inflammatory Effect of LINNEA 315CSE™ on human skin
A study conducted by researchers from the University of Milan, under direction from Professor Mario Dell’Agli, demonstrated the MediCabilis 5% CBD full-spectrum oil to have anti-inflammatory properties in a human skin cell (keratinocyte) model, via the impairment of the NF‐κB pathway.
Sangiovanni E, et al. Cannabis sativa L. extract and cannabidiol inhibit in vitro mediators of skin inflammation and wound injury. Phytother res: PTR. 2019; 33(8): 2083-2093. DOI: https://doi.org/10.1002/ptr.6400