First Health Canada Approved Medical Cannabis Clinical Trial Starts Patient Recruitment

Landmark trial will be first to study safety and efficacy of a series of cannabinoid profiles

SASKATOON, June 23, 2015 /CNW/ - Prairie Plant Systems and CanniMed, Canada's most well-established and reliable producer of medical cannabis, along with researchers at McGill University Health Centre and Dalhousie Universities, officially start patient engagement today on the CAPRI Trial (Cannabinoid Profile Investigation of Vaporized Cannabis in Patients with Osteoarthritis of the Knee), a randomized, double blind, placebo controlled, proof-of-concept, crossover clinical trial of single dose vaporized cannabis in adults with painful osteoarthritis of the knee.

Not only was this clinical trial the first to be registered with Health Canada after the transition to the new Marihuana for Medical Purposes Regulations (MMPR), CAPRI will seek to understand the analgesic dose-response of several varieties of medical cannabis, consisting of varying concentrations of the two most common active ingredients: delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). It will also explore the short-term safety of vaporized cannabis as well as look at functional changes and patient preference.

"Anecdotal evidence supporting cannabis as a medicine is increasing, however this isn't quite good enough for our patients," said Brent Zettl, President and CEO of Prairie Plant Systems Inc. and CanniMed Ltd. "In order for medical cannabis to become a true medicine, it requires carefully conducted trials to provide hard data. It is our ongoing mission to support patients and their prescribing physicians with more research into the safety and efficacy of these cannabis based products to ensure predictable and standardized treatment options in the near future."

The CAPRI Trial will be recruiting 40 patients suffering from serious osteoarthritis of the knee over the two trial sites in Montreal, QC and Halifax, NS. Patient recruitment starts today at the McGill University Health Centre, and Dalhousie University will begin to recruit patients shortly.

"This clinical trial significantly advances medical cannabis research in Canada," said Dr. Mark Ware, CAPRI trial primary investigator and practicing pain physician at the McGill University Health Centre, and Executive Director of the Canadian Consortium for the Investigation of Cannabinoids (CCIC). "This research will help to start answering important questions physicians have regarding dosing as well as short term safety and efficacy related to specific ratios of cannabinoids."

The body's own pain-regulating system, called the endocannabinoid system, has receptors in nervous system tissue, immune cells, bone and joint tissue. These receptors respond to the cannabinoids found in medical cannabis, similar to how a key opens a lock. Research has demonstrated the short term efficacy of medical cannabis at reducing pain when used by itself or in combination with other pain-relievers, but comparisons between cannabinoid ratios have not been tested in clinical settings.

For the 4.6 million Canadians with arthritis, currently available medications are often inadequate or associated with unacceptable side effects. Research into new treatment options, including the potential therapeutic benefit of medical cannabis, is an important next step in determining options available to patients and their caregivers.

"We are very pleased to see that the CAPRI clinical trial is underway and beginning recruitment," said Joanne Simons, chief mission officer, The Arthritis Society. "We know that many people living with arthritis seek alternative options for pain relief, including medical cannabis. Well-designed clinical research is a pre-requisite to get us to where we want to go: more treatment options available to help people manage the pain of arthritis."

About CanniMed and Prairie Plant Systems

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 on patient safety, undertaken 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 13 years, and has been producing safe and consistent medical marijuana for thousands of Canadian patients, with no incident of diversion.

These two companies together have created the leading medical cannabis company in Canada with a strong corporate priority to design and execute clinical research that will close the gap between the anecdotal benefit and evidence based medicine in order to standardize care. Our Canadian-grown cannabis is already leading the way in standardizing care and has been used in a published clinical trial demonstrating the efficacy of smoked cannabis for chronic pain,ⁱ which was used in the development of the Canadian Pain Society's Pharmacological management of chronic neuropathic pain: Revised consensus statement positioning medical cannabis as third line treatment for neuropathic pain.ⁱⁱ

Note for editors:

Interview footage of Brent Zettl (Prairie Plant Systems/CanniMed) and Joanne Simons (The Arthritis Society) are available, along with manufacturing visuals, at the following coordinates: http://www.multivu.com/players/English/7558851-cnw-vod/

An audio news release featuring a quote with Brent Zettl (Prairie Plant Systems/CanniMed) can be heard here: http://www.newscanada.com/mp3/ncradio4260.mp3 and is available for download at the following coordinates: http://www.newscanada.com/radio-new-segments#cat110.

SOURCE Prairie Plant Systems Inc.

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