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Spectrum Therapeutics provides update on its global clinical research program and unveils pharmacovigilance program

Key Takeaway: Spectrum Therapeutics provides update on its global clinical research program and unveils pharmacovigilance program SMITHS FALLS, ON, June 5, 2019 /CNW/ - Spectrum Therapeutics ("Spectrum"), the medical division of Canopy Growth Corporation (TSX: WEED) (NYSE: CGC) (the "Compan

Full Press Release Details

Spectrum Therapeutics provides update
on its global clinical research program and unveils pharmacovigilance program
SMITHS FALLS, ON, June 5, 2019 /CNW/ - 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.
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. (CNW Group/Spectrum Therapeutics)
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 Universit de Montr al. 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.
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 Universit de Montr al 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. Spectrum Therapeutics
sells a range of full-spectrum products using its colour-coded classification Spectrum system as well as single cannabinoid Dronabinol
under the brand Bionorica Ethics.
The Company operates retail stores across Canada
under its award-winning Tweed and Tokyo Smoke banners. Tweed is a globally recognized cannabis brand which has built a large and
loyal following by focusing on quality products and meaningful customer relationships.
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
Last updated: Jun 5, 2019