Spectrum Therapeutics Provides Update on its Global Clinical Research Program and Unveils Pharmacovigilance Program

Published: June 6, 2019

Spectrum Therapeutics Provides Update on its Global Clinical Research Program and Unveils Pharmacovigilance Program

Spectrum Therapeutics (“Spectrum”), the medical division of Canopy Growth Corporation shared 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. 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.

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.”