SMITHS FALLS, Ontario,
June 6, 2019 /PRNewswire/ -- Spectrum
Therapeutics ("Spectrum"), the medical division of Canopy Growth
Corporation (TSX: WEED) (NYSE: CGC) (the "Company" or "Canopy
Growth") is pleased to share an update on its efforts to develop
and commercialize validated cannabis medicines through clinical
trials. Demand for cannabinoid-based medicines is emerging around
the world. With a highly experienced scientific team and the
resources needed to conduct robust clinical trials, Spectrum
Therapeutics is pursuing research to introduce products for the
therapeutic areas of pain, mood and sleep and to gain access to new
markets independent of medical cannabis laws.
CLINICAL RESEARCH
Spectrum Therapeutics is focused over the next 24 months to
further the science of cannabinoids and provide evidence by way of
clinical trials on what conditions medical cannabis can treat. This
research includes product design and ingredient selection,
formulation, and safety and efficacy testing towards the
development of standardized cannabis drug formulations and dose
delivery systems. Research activity is occurring in two main areas:
registration trials and exploratory studies.
Registration trials begin with phase I studies of cannabinoid
products covering a spectrum of proprietary THC and CBD ratios.
These initial trials provide critical dosing and safety data to
inform subsequent phase II trials. Spectrum Therapeutics is pleased
to announce that two phase I trials have already been completed,
one each in Canada and
Chile.
Exploratory "proof of concept" studies use a range of Spectrum
products and design methodologies to explore different dose
responses, and safety and efficacy signals for target conditions.
Those that show promising results will be added to the registration
trial pipeline and their initial findings will allow for optimal
phase II trial design. The first proof of concept phase IIb "in
human" clinical trial previously announced by the Company, to
evaluate the use of medical cannabis for treating insomnia, is in
progress in partnership with Drs. Julie
Carrier and Alex Desautels at
the Université de Montréal. It is expected to be completed by
calendar Q2 2020 with results announced by calendar Q3 2020.
Other proof of concept studies are currently underway in
partnership with researchers including Dr. Bernard Le Foll at the Centre for Addiction and
Mental Health, Dr. Mary-Ann
Fitzcharles at McGill
University, and Dr. Angela
Genge at the Montreal Neurological Institute. Over twenty
conditions are being examined across these studies, including pain,
sleep, and mood/anxiety disorders. Spectrum Therapeutics is also
exploring areas such as neurodegenerative disorders in addition to
the previously announced research partnership with NEEKA Health
Canada and the NHL Alumni Association which is examining the
efficacy of CBD-based therapies as part of a treatment for
concussion symptoms. This clinical trial is expected to register
its first patients by October 2019
with preliminary results by July
2020.
Recently acquired C3 Cannabinoid Compound
Company ("C3") is currently progressing a clinical trial
for the use of dronabinol to treat spasticity due to multiple
sclerosis. Additionally, research on the potential of medical
cannabis to treat cancer-related pain is also in the works with
Beckley Canopy Therapeutics, a partnership established between U.K.
drug research institute, The Beckley Foundation and Canopy Growth.
Patient registrations for this trial are expected in September 2019.
To support its research program, Spectrum Therapeutics is
pleased to announce the appointment of Dr. Marcel Bonn-Miller as Global Clinical Scientific
Director. He brings to the team 18 years of experience researching
cannabinoids and their various effects, has received funding for 27
research grants, and has led or contributed to 19 clinical trials.
His work has been featured in 139 academic publications and 161
conference presentations, and he also serves on the editorial
boards of five academic journals. Dr. Bonn-Miller previously worked
as Director of Cannabinoid Research for Zynerba Pharmaceuticals, a
leading transdermal cannabinoid pharmaceutical company. He is also
an adjunct Assistant Professor at the University of Pennsylvania Perelman School of
Medicine, known for his work examining the potential of cannabis in
treating post-traumatic stress disorder.
Dr. Bonn-Miller will be supported by Hunter Land and Drs. Ryan Lanier and Erica
Peters as Associate Directors. Land was instrumental in
bringing the first cannabis-derived CBD medicine developed for
patients with treatment-resistant forms of epilepsy, including
Dravet and Lennox-Gastaut syndromes, to FDA approval. Dr. Peters
was the lead clinical cannabis scientist for four years at
Battelle, the world's largest non-profit research and development
organization, and Dr. Lanier worked for Analgesic Solutions where
he consulted on the development of pain medications for FDA
approval.
PHARMACOVIGILANCE
In the interest of patient safety and good clinical practice,
Spectrum Therapeutics is pleased to announce the implementation of
a unique global pharmacovigilance program to capture and document
adverse events reported from the worldwide use of its medical
cannabis products in addition to the Company's Canadian
recreational cannabis brands including Tweed and DNA Genetics, and
its CBD product offerings.
Pharmacovigilance, also known as drug safety, is defined as the
science and activities relating to the detection, assessment,
understanding and prevention of adverse effects from the use of
pharmaceutical products. While Spectrum Therapeutics and Canopy
Growth were already reporting any adverse reactions to its cannabis
products as per Health Canada regulations, the launch of this
global pharmacovigilance program ensures that all employees are
trained on how to identify and report adverse events. The Company's
internal Pharmacovigilance team is responsible for analyzing and
entering events into a global safety database compliant with
regional regulatory requirements.
A global independent safety monitoring board chaired by
Professor Yola Moride at the
Université de Montréal will periodically review adverse event
summaries and advise the Spectrum Therapeutics scientific team
regarding product safety and clinical trial design.
"We believe that this strategic approach to global clinical
research, in collaboration with outstanding investigators and
institutions, and supported by our first-rate team of scientists,
will generate innovative products for a number of indications with
significant unmet needs," commented Dr. Mark Ware, Chief Medical Officer, Canopy Growth.
"We are also pleased to announce the launch of our global
pharmacovigilance program whereby every one of our 3000+ staff
worldwide are trained in reporting adverse events. It's an
important step towards establishing drug safety and will advance
our efforts to provide patients with accepted, clinically validated
cannabis medicines while transparently demonstrating the relative
risks of cannabis."
Here's to (Clinically Validated) Future Growth.
About Canopy Growth Corporation
Canopy Growth (TSX: WEED) (NYSE: CGC) is a world-leading
diversified cannabis, hemp and cannabis device company, offering
distinct brands and curated cannabis varieties in dried, oil and
Softgel capsule forms, as well as medical devices through the
Company's subsidiary, Storz & Bickel GMbH & Co. KG. From
product and process innovation to market execution, Canopy Growth
is driven by a passion for leadership and a commitment to building
a world-class cannabis company one product, site and country at a
time. The Company has operations in over a dozen countries across
five continents.
The Company's medical division, Spectrum Therapeutics is proudly
dedicated to educating healthcare practitioners, conducting robust
clinical research, and furthering the public's understanding of
cannabis, and has devoted millions of dollars toward cutting edge,
commercializable research and IP development.
From our historic public listing on the Toronto Stock Exchange
and New York Stock Exchange to our continued international
expansion, pride in advancing shareholder value through leadership
is engrained in all we do at Canopy Growth. Canopy Growth has
established partnerships with leading sector names including
cannabis icons Snoop Dogg and Seth
Rogen, breeding legends DNA Genetics and Green House Seeds,
and Fortune 500 alcohol leader Constellation Brands, to name but a
few. Canopy Growth operates ten licensed cannabis production sites
with over 4.4 million square feet of production capacity, including
over one million square feet of GMP certified production space. For
more information visit www.canopygrowth.com
Notice Regarding Forward Looking Statements
This news release contains "forward-looking statements" within
the meaning of the United States Private Securities Litigation
Reform Act of 1995 and "forward-looking information" within the
meaning of applicable Canadian securities legislation. Often, but
not always, forward-looking statements and information can be
identified by the use of words such as "plans", "expects" or "does
not expect", "is expected", "estimates", "intends", "anticipates"
or "does not anticipate", or "believes", or variations of such
words and phrases or state that certain actions, events or results
"may", "could", "would", "might" or "will" be taken, occur or be
achieved. Forward-looking statements or information involve known
and unknown risks, uncertainties and other factors which may cause
the actual results, performance or achievements of Canopy Growth or
its subsidiaries to be materially different from any future
results, performance or achievements expressed or implied by the
forward-looking statements or information contained in this news
release. Examples of such statements include "expected to be
completed by Q2 2020 with results announced by Q3 2020", and "those
that show promising results will be added to the registration trial
pipeline". Risks, uncertainties and other factors involved with
forward-looking information could cause actual events, results,
performance, prospects and opportunities to differ materially from
those expressed or implied by such forward-looking information,
including clinical trial results, product supply, and such risks
contained in the Company's annual information form dated
June 27, 2018 and filed with Canadian
securities regulators available on the Company's issuer profile on
SEDAR at www.sedar.com. Although the Company believes that the
assumptions and factors used in preparing the forward-looking
information or forward-looking statements in this news release are
reasonable, undue reliance should not be placed on such information
and no assurance can be given that such events will occur in the
disclosed time frames or at all. The forward-looking information
and forward-looking statements included in this news release are
made as of the date of this news release and the Company does not
undertake an obligation to publicly update such forward-looking
information or forward-looking information to reflect new
information, subsequent events or otherwise unless required by
applicable securities laws.
Contact:
Caitlin O'Hara
Media Relations
Caitlin.ohara@canopygrowth.com
+1-613-291-3239
Tyler Burns
Investor Relations
Tyler.burns@canopygrowth.com
+1-855-558-9333 ex 122