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Tilray, Inc., a global leader in cannabis research and production, has announced its support of two new clinical studies. The first is a pilot study led by Murdoch Children’s Research Institute (MCRI) in Melbourne, to evaluate the feasibility and acceptability of a larger randomised placebo-controlled trial of cannabis extract as a form of treatment for reducing Severe Behavioral Problems in paediatric patients with Intellectual Disabilities.
The second piece of research is in collaboration with McGill University Health Centre’s Division of Infectious Diseases and Chronic Viral Illness, to examine the effectiveness of medical cannabis on immune activation in people living with HIV.
“Tilray is at the forefront of clinical research in the medical cannabis field and we’re very proud to support two groundbreaking studies that have potential to identify more indications in which medical cannabis can benefit patients in-need,” says Philippe Lucas, VP of Global Patient Research and Access, Tilray. “We are committed to advancing cannabinoid-based science to further understand the potential benefits of medical cannabis as a treatment option among these critical patient populations. There is a serious need for more clinical data in our field, and we are proud to support research like this around the world.”
Over 50,000 youth in Australia suffer from an Intellectual Disability with Severe Behavioural Problems such as irritability, aggression, and self-injury. Anti-psychotic and other psychotropic medications are prescribed for half of these patients in Australia, despite limited evidence for their efficacy and a high risk of serious side-effects, including weight gain, metabolic syndrome and extrapyramidal movement disorders. Polypharmacy and off-label prescribing are common in these patients, and drugs are sometimes added to treat side effects.
Research to date suggests that CBD and other cannabis extracts, have had fewer reported side-effects than anti-psychotic medications; however, there is currently insufficient evidence to inform its use in treating SBP. MCRI is among the first institutions to conduct research specifically testing the effectiveness of CBD on patients with intellectual disabilities to reduce severe behavioural problems.
“We are committed to increasing the scientific understanding of cannabinoid-based medicine as treatment for paediatric patients with intellectual disability and associated severe behavioural problems through this study.” says Associate Professor Daryl Efron, senior researcher at MCRI and pediatrician.
The single site, double-blind, parallel group, randomised, placebo-controlled pilot study of 10 participants, compares CBD with a placebo in reducing Severe Behavioural Problems in paediatric patients aged eight to 16 years of age with Intellectual Disability. Participants are randomized 1:1 to receive either Tilray C100 oral solution or the placebo.
Tilray supplied the medical cannabis products used for this trial which were successfully exported from Tilray’s Good Manufacturing Practices (GMP) certified facility in Nanaimo, British, Columbia, Canada to Australia in early 2019, with the trial commencing shortly thereafter. The results from this trial are expected to be published by 2020.
Despite antiretroviral therapy (ART), persistent immune activation is associated with increased risk of non-opportunistic complications in people living with HIV, such as cardiovascular, pulmonary, renal and hepatic events. Research has suggested that medical cannabis may hold many potential therapeutic benefits for PLWH due to its promising anti-inflammatory and anti-fibrotic effects.
The use of medical cannabis to potentially benefit people living with HIV has been largely unexplored due to regulatory restrictions which impeded its thorough evaluation in the past decade. The changing regulatory environment and access to high-quality pharmaceutical-grade cannabis products has allowed researchers to begin generating critical data in support of this patient population, living with a number of difficult-to-treat conditions. The trial will contribute to a growing body of evidence in support of medical cannabis as a treatment option for people living with HIV, and provide important data on the anti-inflammatory effects of cannabinoids.
“There is a critical need for more data on methods to reduce chronic immune activation in People Living with HIV,” says Dr. Cecilia T. Costiniuk, MD, MSc, Assistant Professor at McGill University, Division of Infectious Diseases, and Lead Investigator on the study. “We hope can demonstrate that THC and CBD capsules consumed orally are safe and well-tolerated in PLWH and can contribute to improving the quality of the patient’s life.”
The randomized open-label interventional study will measure the safety, tolerability and effectiveness of Tilray oral capsules: a THC and CBD balanced low dose capsule and a low THC and mid/high CBD concentration capsule, on immune activation in People Living with HIV. The first phase of the trial will call for 26 participants aged 18 years or older living with diagnosed HIV, separated into two groups, who will undergo medical cannabis treatment for 12 weeks.
The trial is expected to begin in the second half of 2019.