Tilray cannabis products will be used to support the Murdoch
Children’s Research Institute led pilot study to evaluate the
feasibility and acceptability of a randomized placebo-controlled trial
of the efficacy of cannabidiol (CBD) oral solution in reducing Severe
Behavioral Problems in children with Intellectual Disabilities
Tilray CBD and THC capsules will be used in a study examining the
safety, tolerability and effectiveness of medical cannabis on immune
activation in people living with HIV being conducted by the McGill
University Health Centre
Tilray’s support of numerous studies conducted by leading research
institutions and hospitals around the world reflects the need for more
clinical data in the medical cannabis field and the Company’s commitment
to advancing cannabinoid-based science to further understand the
benefits it can offer to critical patient populations
NANAIMO, British Columbia–(BUSINESS WIRE)–Tilray, Inc. (NASDAQ:TLRY), a global leader in cannabis research and
production, today announced its support of two new clinical studies: a
pilot study led by Murdoch Children’s Research Institute (MCRI) in
Melbourne, to evaluate the feasibility and acceptability of a larger
randomized placebo-controlled trial of cannabis extract as
a form of treatment for reducing Severe Behavioral Problems (SBP) in
pediatric patients with Intellectual Disabilities (ID); and a study 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.”
Murdoch Children’s Research Institute in Australia:
Over 50,000 youth in Australia today have 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, 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. Novel
interventions are urgently needed for this highly vulnerable patient
group.
The American Academy of Pediatrics and the Royal Australasian College of
Physicians have highlighted the need for 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 SBP
in youth with ID. 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 behavioral problems.
“We are committed to increasing the scientific understanding of
cannabinoid-based medicine as treatment for pediatric patients with
intellectual disability and associated severe behavioral problems
through this study.” says Associate Professor Daryl Efron, senior
researcher at MCRI and pediatrician.
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 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.
McGill University Health Centre’s Division of Infectious Diseases and
Chronic Viral Illness:
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 led by McGill University Health
Centre’s Division of Infectious Diseases and Chronic Viral Illness will
contribute to a growing body of evidence in support of medical cannabis
as 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. More
information about the trial will be shared in the coming months.
About Tilray®
Tilray is a global pioneer in the research, cultivation, production and
distribution of cannabis and cannabinoids currently serving tens of
thousands of patients and consumers in twelve countries spanning five
continents.
Cautionary note regarding forward-looking statements:
This press release contains “forward-looking statements” within the
meaning of the U.S. Private Securities Litigation Reform Act of 1995 and
“forward-looking information” within the meaning of Canadian securities
laws, or collectively, forward-looking statements. Forward-looking
statements in this press release may be identified by the use of words
such as, “may”, “would”, “could”, “will”, “likely”, “expect”,
“anticipate”, “believe, “intend”, “plan”, “forecast”, “project”,
“estimate”, “outlook” and other similar expressions, including
statements in respect to Tilray’s medical cannabis products.
Forward-looking statements are not a guarantee of future performance and
are based upon a number of estimates and assumptions of management in
light of management’s experience and perception of trends, current
conditions and expected developments, as well as other factors that
management believes to be relevant and reasonable in the circumstances,
including assumptions in respect of current and future market
conditions, the current and future regulatory environment and future
approvals and permits. Actual results, performance or achievement could
differ materially from that expressed in, or implied by, any
forward-looking statements in this press release, and, accordingly, you
should not place undue reliance on any such forward-looking statements
and they are not guarantees of future results. Please see the heading
“Risk Factors” in Tilray’s Annual Report on Form 10-K, which was filed
with the Securities and Exchange Commission and Canadian securities
regulators on March 25, 2019, assumptions, uncertainties and other
factors that may cause actual future results or anticipated events to
differ materially from those expressed or implied in any forward-looking
statements. Tilray does not undertake and specifically declines any
obligation to update any forward-looking statements that are included
herein, except in accordance with applicable securities laws.
Contacts
For further information:
Media: Chrissy Roebuck,
+1-833-206-8161, news@tilray.com
Investors:
Katie Turner, +1-646-277-1228, Katie.turner@icrinc.com
Patients
in Australia and New Zealand: 1800-361-664, infoanz@tilray.com
Patients
in Canada: 1-844-845-7291, tilray@tilray.ca