SASKATOON, May 22, 2014 – Prairie Plant Systems Inc., parent company of CanniMed Ltd., announced today that Health Canada has formally approved a clinical trial application for a randomized, double blind, placebo controlled, proof-of-concept, crossover clinical trial of vapourized cannabis in adults with painful osteoarthritis of the knee.
This clinical trial is the first to be registered with Health Canada after the transition to the new Marihuana for Medical Purposes Regulations (MMPR)). This trial will study the dose-response of several varieties of medical marijuana, consisting of varying degrees of the two most common active ingredients: delta-9- tetrahydrocannabinol (THC) and cannabidiol (CBD). It will also explore the short-term safety of vapourized cannabis as well as to look at functional changes and patient preference.
Prairie Plant Systems is currently finalizing the agreements with the two main trial sites. Patient recruitment details will be announced in the coming weeks.
“With 36 per cent of the patients registered in the former MMAR program suffering with symptoms of severe arthritis – the largest concentration of any disease area – we felt there was no option but to continue our clinical exploration within this important patient group,” said Brent Zettl, President and CEO of Prairie Plant Systems and CanniMed. “Today we are announcing the launch of our clinical trial program where we will formally study several varieties of medical marijuana to determine not only the safety and efficacy of pharmaceutical-grade cannabis, but also to provide prescribing physicians with the clinical data they are looking for regarding dosing.”
Studies show that the body’s own pain-regulating system, (the endocannabinoid system) has receptors in nervous system tissue, immune cells, bone and joint tissue. These receptors respond to the cannabinoids found in medical marijuana, similar to how a key opens a lock. Medical marijuana research has demonstrated its efficacy at reducing pain when used by itself or in combination with other pain-relievers. Many cases of anecdotal evidence have been reported for arthritis patients who have very successfully used medical marijuana either in conjunction with traditional therapy or alone.
“Well designed controlled trials are needed to answer many of the claims made around medical cannabis,” says Dr. Mark Ware, executive director of the Canadian Consortium for the Investigation of Cannabinoids (CCIC) and a practicing pain physician at the McGill University Health Centre. “We are continually looking for options to help treat patients who do not respond to traditional pharmacotherapy. Research of this kind will start answering some important questions about dose and efficacy, use of vapourization as a delivery system in clinical practice, and hopefully will encourage other licensed producers to join in the research endeavours.”
For the 4.6 million Canadians with arthritis, anti-inflammatory and analgesic medications are the only current options available for symptom management. While effective for the majority of patients, there are some cases where current medication just isn’t enough to control the pain and inflammation.
“We know that many people living with arthritis actively seek alternative options for pain relief,” said Joanne Simons, chief mission officer, The Arthritis Society. ”Knowing that, we are very pleased to see that a clinical trial specific to osteoarthritis of the knee has been registered with Health Canada. Clinical research is the necessary first step to get us to where we want to go: more treatment options available for the arthritis community.”
About CanniMed Ltd. and Prairie Plant Systems Inc.
CanniMed Ltd. was the first producer to be licensed under the new Marihuana for Medical Purposes Regulations (MMPR). Our pharmaceutical-grade marijuana is produced under Good Manufacturing Practices (GMP) regulations, the criteria used to manufacture all pharmaceuticals in Canada. Our primary focus is patient safety by strictly following a 281 point quality control process.
CanniMed’s parent company, Prairie Plant Systems Inc. was the sole supplier to Health Canada under the former medical marijuana system for the last 13 years, and has been producing safe and consistent medical marijuana for thousands of Canadian patients, with no incident of diversion.
It is our top priority to lead the new Canadian medical marijuana industry through our participation in clinical research that will close the gap between the anecdotal benefit and evidence based medicine in order to standardize care. Additionally, we are the only Canadian Licensed Producer who can boast that our pharmaceutical-grade cannabis has been used in a published clinical trial demonstrating the efficacy of smoked cannabis for chronic pain.1
Our goal is to provide improved access for Canadians who rely on medical marijuana through scientific collaborations with external partners including academic institutions and healthcare professionals.
An audio news release featuring a quote with Brent Zettl (Prairie Plant Systems/CanniMed) is available at the following coordinates: newscanada.com/mp3