Tilray (NASDAQ: TLRY), which is engaged in cannabis research and production, said it is supporting two new clinical studies in Australia and Canada.
In Australia, Murdoch Children’s Research Institute (MCRI) is beginning a pilot study in Melbourne to evaluate the feasibility of a larger randomized placebo-controlled trial of cannabis extract as a form of treatment for reducing severe behavioral problems in pediatric patients with intellectual disabilities.
In Canada, a study is being conducted by the 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.
Murdoch Children’s Study
Over 50,000 youth in Australia today have the intellectual disability with severe behavioral problems such as irritability, aggression, and self-injury. Anti-psychotic and other psychotropic medications are prescribed for half of these patients in Australia.
But all these treatments aren’t very effective and offer a risk of serious side-effects, including weight gain, metabolic syndrome and extrapyramidal movement disorders. So, novel interventions are needed for this highly-vulnerable patient group.
The American Academy of Pediatrics and the Royal Australasian College of Physicians have suggested further research into the therapeutic uses of cannabinoids in youth. There is intense interest from parents and physicians in medical cannabis as a treatment for severe behavioral problems in youth with the intellectual disability.
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 severe behavioral problems.
“We are committed to increasing the scientific understanding of cannabinoid-based medicine as [a] treatment for pediatric patients with intellectual disability and associated severe behavioral problems through this study,” Associate Professor Daryl Efron, senior researcher at MCRI and pediatrician, said in a statement.
The single site, double-blind, parallel group, randomized, placebo-controlled pilot study of 10 participants, compares CBD with a placebo in reducing severe behavioral problems in pediatric patients aged eight to 16 years of age with the intellectual disability. Participants are randomized 1:1 to receive either Tilray C100 oral solution or the placebo.
The results from the trial are expected to be published by 2020.
McGill University Health Centre’s Study
The trial led by McGill University Health Centre will focus on using medical cannabis to treat people living with HIV and provide important data on the anti-inflammatory effects of cannabinoids.
Research indicates medical cannabis may hold many potential therapeutic benefits for people living with HIV 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 pharmaceutical-grade cannabis products have allowed researchers to begin generating critical data in support of this patient population, living with a number of difficult-to-treat conditions.
“There is a critical need for more data on methods to reduce chronic immune activation in People Living with HIV,” Dr. Cecilia Costiniuk, assistant professor at McGill University and lead investigator on the study, said in prepared remarks. “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.
Tilray Supports These Groundbreaking Studies
Philippe Lucas, vice president of global patient research and access at Tilray, said that their company “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.”
“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,” Lucas stated.
Tilray supplied its medical cannabis products for the trials that were developed at the company’s GMP-certified facility in Nanaimo, British, Columbia, Canada.