Country for PR: United States
Contributor: PR Newswire New York
Wednesday, June 05 2019 - 21:10
AsiaNet
Spectrum Therapeutics provides update on its global clinical research program and unveils pharmacovigilance program
SMITHS FALLS, Ontario, June 5, 2019 /PRNewswire-AsiaNet/ --

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. 
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 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.

For further information: Caitlin O'Hara, Media Relations, 
Caitlin.ohara@canopygrowth.com, 613-291-3239; Tyler Burns, Investor Relations, 
Tyler.burns@canopygrowth.com, 855-558-9333 ex 122

Source - Spectrum Therapeutics