Tilray® Receives Approval from U.S. Government to Import a Medical Cannabis Study Drug for a Clinical Trial at the Universit...
September 18 2018 - 7:00AM
Business Wire
U.S. Drug Enforcement Administration
approves import of a pharmaceutical-grade medical cannabis product
produced by Tilray into the United States for a clinical trial
focused on Essential Tremor
Tilray Inc. (NASDAQ:TLRY) today announced that the U.S. Drug
Enforcement Administration (DEA) has granted approval to import a
cannabinoid study drug into the United States from Canada for a
clinical trial at the University of California San Diego (UC San
Diego) Center for Medicinal Cannabis Research (CMCR) examining its
safety, tolerability and efficacy for Essential Tremor (ET).
Tilray is providing a cannabinoid formulation for the trial in
capsule form, which will allow researchers to test an
investigational drug product containing two active ingredients
extracted from the cannabis plant, cannabidiol (CBD) and
tetrahydrocannabinol (THC). Dr. Fatta Nahab, a board-certified
neurologist and director of the Functional Imaging of
Neurodegenerative Disorders Lab at the UC San Diego Health’s
Movement Disorder Center, will serve as the principal investigator
for the study. It is expected to begin in early 2019 with financial
support from Tilray and the International Essential Tremor
Foundation.
“Tilray is proud to support this crucial research,” says Dr.
Catherine Jacobson, Director of Clinical Research at Tilray. “If
this study can identify cannabinoids as a potential treatment for
patients suffering from essential tremor, we can conduct further
research and potentially provide alternative effective methods of
relief for the high numbers of patients with ET.”
Essential Tremor is a neurological movement disorder
characterized by involuntary and rhythmic shaking. ET has extremely
high prevalence rates; 0.4% of the general population suffer from
ET, and that figure rises to 4.6%-6.3% among those 65 and older.
Essential Tremor can have a significant impact on a patient’s
quality of life, causing embarrassment, social withdrawal,
disability, and loss of occupation. Many patients do not experience
relief with the current drugs on the market or find the
side-effects of these drugs to be unbearable.
Additional Quotes:
- “It’s exciting to advance our work in
this area by conducting a first-of-its kind trial of purified
medicinal cannabis for a common neurological disorder like
essential tremor,” says Dr. Nahab. “Until now patients have been on
their own to figure out the efficacy, safety, and dosing of
cannabinoids. This trial should help answer many of these critical
questions.”
- “We are extremely enthusiastic about
the initiation of this study, extending as it does CMCR’s program
to discover therapeutic potential of various cannabinoid
preparations,” said Dr. Igor Grant, Center for Medicinal Cannabis
Research Director. “These studies are promising to uncover new
treatments for difficult to treat conditions.”
- “The IETF is proud to provide grant
funding for this study which provides hope to the essential tremor
community,” said Patrick McCartney, executive director of the
International Essential Tremor Foundation. “The effectiveness of
cannabis as a treatment for essential tremor has long been a topic
of interest in the ET community. We are grateful to Dr. Nahab and
UC San Diego Center for Medicinal Cannabis Research for their
dedication to scientific research of this kind. And we commend
Tilray for the development of this study drug which has the
potential to help thousands of people who struggle with ET.”
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 in eleven countries spanning
five continents.
About the Center of Medicinal Cannabis Research
Established in 2000, the UC San Diego Center for Medicinal
Cannabis Research (CMCR) has been at the forefront of advancing
science and policy relating to the potential clinical benefits and
limitations of cannabis and cannabinoids as medicine. With support
from the California State Legislature, CMCR initiated the first
therapeutic studies using smoked cannabis in over 20 years,
completed seven key studies regarding the short-term benefits of
cannabis for the treatment of neuropathic pain and spasticity, and
has numerous active research projects, funded by both the State and
National Institutes of Health. Since its inception, CMCR has
strived to collaborate and maintain productive relationships with
key Federal and State agencies.
About The International Essential Tremor Foundation
Headquartered in Lenexa, KS, the International Essential Tremor
Foundation is the leading organization in the world dedicated to
those affected by essential tremor. The mission of the IETF is to
provide hope to the essential tremor (ET) community worldwide
through awareness, education, support, and research.
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
intention to import cannabis products for research purposes.
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. Forward-looking
statements involve significant risks, including the risks discussed
under the caption “Risk Factors” in Tilray, Inc.’s Quarterly Report
on Form 10-Q for the three and six months ended June 30, 2018 (a
copy of which may be obtained at www.sec.gov and www.sedar.com),
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20180918005163/en/
Tilray Media:Chrissy Roebuck,
+1-416-560-5712chrissy.roebuck@tilray.comorTilray
Investors:Katie Turner,
+1-646-277-1228Katie.turner@icrinc.com
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