EQUAL (Evaluation QUAlity of Life) Clinical
Research Initiative Will Gather Anonymized Patient Data on Effects
of Medical Cannabis
TORONTO,
Sept. 17, 2015 /CNW/ - Bedrocan
Canada Inc. ("Bedrocan" or the "Company"), a subsidiary of Tweed
Marijuana Inc. (TSXV: TWD) ("TMI" or "Tweed"), along with its
sister company Tweed Inc., is pleased to announce the launch of the
EQUAL (Evaluation QUAlity of Life) study. The clinical research
initiative is a multi-centre, non-interventional, un-blinded study
to evaluate quality of life in Canadian patients treated with
medical cannabis. The company-sponsored study will evaluate
patients who use Bedrocan and Tweed strains of cannabis to help
manage symptoms of a range of chronic health conditions, and the
resulting data will be submitted for publication by a peer-reviewed
medical journal. To ensure patient privacy, all data collected will
be anonymized and stored in a secure electronic database.
The primary objective of the study, which is
intended to continue for three years, include more than 50 sites,
and enroll up to 6,000 patients, is to evaluate the quality of life
(QoL) of patients before and after treatment with medical cannabis.
The study will use a well-established general QoL assessment
instrument, the SF-36, and will record both positive and negative
effects attributed to treatment.
The study will include patients registered under
Health Canada's Marijuana for Medical Purposes Regulations
(MMPR), who use Bedrocan and Tweed strains, and who volunteer to
participate. Patients will be compensated for their participation
via discounted cost of product used during the period of the study
(12 months per patient), and clinical sites participating in the
study will receive a nominal fee for the time required to complete
and submit subject surveys of a patient.
The study will not include patients from
Quebec, for whom a separate,
independent research study was launched in May, 2015, as part of
the Quebec Cannabis Registry. Bedrocan and Tweed, along with
another licensed producer, are supporting the launch of the Quebec
Registry via funding provided to the Canadian Consortium for the
Investigation of Cannabinoids (CCIC), and the CCIC has provided a
grant to the Research Institute of the McGill
University Health Centre (RI-MUHC), to support the first
year of the Registry's operations.
"This will be one of the world's largest studies
on the therapeutic effects of medical cannabis, and will generate
extremely valuable patient-level data on treatment benefits, risks
and side effects," said Marc Wayne,
President of Bedrocan Canada. "Tens of thousands of Canadian
patients are currently using cannabis to manage symptoms from
conditions ranging from chronic pain, to certain mental illnesses,
multiple sclerosis, arthritis, spinal cord injury, HIV/AIDS,
intractable forms of epilepsy and other conditions. We are
launching this study to advance the science associated with medical
cannabis, to provide the medical community with useful insights
into its effect on quality of life, and to gather data specific to
the effects of Bedrocan and Tweed strains in patients who use our
products."
The principal investigator for the study is Dr.
Martin A. Katzman, Director of the
START (Stress, Trauma, Anxiety, Rehabilitation and Treatment)
Clinic for Mood and Anxiety Disorders, and on faculty at both the
Faculty of Medicine, University of
Toronto as well as the Northern Ontario School of Medicine
(NOSM). Dr. Katzman is also Chair of the Scientific Advisory Board
of the Anxiety Disorders Association of Canada and a member of Bedrocan Canada's
Medical Advisory Board.
"As the number of patients using medical cannabis
increases, we have an urgent need to add to the body of literature
and compile real-world data on who is using medical cannabis, how
patients respond to prescribed cannabis, and what it can and cannot
achieve as a treatment option," said Dr. Katzman. "No one in the
medical community is recommending medical cannabis as a first-line
therapy, but we know it is being used increasingly by patients
refractory to conventional prescription drugs, or who cannot
tolerate the side effects of conventional therapies. This study
will provide the medical community with data we need, to understand
how medical cannabis affects quality of life in patients with a
number of different diagnoses and treatment regimens."
The clinical study will be launching with an
initial three sites in Ontario and
British Columbia: Wellmedica in
Woodbridge, Ontario, Greendot
Medical Clinic in Brantford,
Ontario, and Greenleaf Medical Clinic in Abbotsford, British Columbia. Physicians and
clinics who are interested in supporting this option for their
patients and would like to contribute to the growing body of
evidence for the appropriate therapeutic use of cannabis are
encouraged to contact EQUAL@bedrocan.ca or EQUAL@tweed.com for more
information.
DSG, Inc., a leading clinical data capture and
management company based in Malvern,
Pennsylvania, will provide their flagship eCaseLink™
electronic data capture (EDC) and Electronic Patient Reported
Outcomes (ePRO) services for the study.
About Bedrocan
Bedrocan Canada is focused on clinical research,
technologically-advanced, automated production processes,
innovative product development, and environmentally responsible
production and operation. The Company produces six strains of
medical cannabis, and has two facilities in the Greater Toronto Area licensed by Health Canada
under the Marihuana for Medical Purposes Regulations.
Bedrocan Canada and its licensor Bedrocan Beheer BV (Netherlands) are the only companies in the
world currently capable of producing standardized full-bud,
pharmaceutical-grade medicinal cannabis. www.bedrocan.ca
About Tweed Marijuana Inc.
Tweed Marijuana Inc. is Canada's first
publicly traded medical marijuana company and the first
geographically diversified producer with a total of four licenses
under the Marihuana for Medical Purposes Regulations.
Through its wholly owned subsidiaries, Tweed, Tweed Farms, and
Bedrocan Canada, the Company operates three state-of-the-art
production facilities in Ontario, and distributes
marijuana across the country to Canadian patients managing a host
of medical conditions. The Company is dedicated to educating
healthcare practitioners, providing consistent access to high
quality medication, and furthering the public's understanding of
how marijuana is used for medical purposes. www.tweed.com
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the adequacy or accuracy of this release.
SOURCE Bedrocan Cannabis Corp