Quebec-based medical cannabis clinic and resource centre Santé Cannabis has announced its expansion, making it “Canada’s first independently credentialed centre of excellence in cannabis research.”
Using a one-of-a-kind clinic model, the organization “provides clinical research services to the pharmaceutical, biotech, and cannabis industries focused on the investigation and development of cannabis and cannabinoid products,” according to a July 18 press release.
Santé Cannabis was founded in 2014. On top of its focus on clinical research, the organization provides legal medical cannabis prescriptions, as well as patient assessments and follow-up care. With centres in Sherbrooke, Montreal and Quebec City, Santé Cannabis is expected to open further clinical research centres later in 2018.
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Better access, more research
Santé Cannabis President and Co-Founder Erin Prosk lauded the expansion in the presser, saying “the greatest obstacle to a patient’s access to cannabis is the limited clinical, scientific evidence.”
”For years now, we have heard about the lack of evidence to support the medical use of cannabis, we can’t just keep talking about it. Our patients deserve better, they need action. At Santé Cannabis, we are committed to building the body of scientific evidence and to leading medical cannabis products into the pharmacy and into prescription drug coverage.”
“Research is fundamental to building a body of scientific evidence that holds up to the most rigorous standards required by regulators like Health Canada, healthcare professionals and payers. The lack of independent, evidence-based research has been a major obstacle to patient access. Evidence is what the medical community has been asking for before they will consider cannabis as a therapeutic option for their patients,” Prosk told Daily Hive via email.
Abolition of service fees
With its new status as a Contract Research Organization (CRO), Santé Cannabis has access to funding for its clinical research program. As a result, the organization announced that it is taking measures to make cannabis even more accessible to medical users by “eliminating all patient fees for its current and future medical cannabis patients.”
Calling it a “huge milestone” for patients in Quebec, Prosk stated that “service fees at Santé Cannabis were an unfortunate necessity in order to meet regulatory requirements. We are pleased to announce today the removal of one barrier to medical cannabis access and we are grateful for the support of our partners and the commitment of our patients to support our research goals.”
“Medical cannabis has an important therapeutic role for patients experiencing pain and other symptoms that significantly impact quality of life and are unrelieved by conventional treatments,” said Dr. Antonio Vigano, Research Director of Santé Cannabis.
Dr. Vigano is an Attending Physician in the Supportive and Palliative Care Division at the McGill University Health Centre, and an Associate Professor in the Department of Oncology at McGill, in addition to working as the Principal Investigator of two medical cannabis clinical trials currently recruiting at Santé Cannabis.
“Our work has established Santé Cannabis as a Canadian and international leader committed to answering the remaining questions about the safety, efficacy and clinic use of medical cannabis products and will provide guidance for physicians and healthcare professionals,” Dr. Vigano said in a press release.
Prosk agrees. “That is why we are so committed to research,” she says.
“It’s the path to bringing cannabis to the pharmacy where patients will have easier access to it, and have it covered by insurance. It’s also worthy to note that we see more and more physicians who want to become educated about cannabis and we support them through education programs at Santé Cannabis so they can safely prescribe cannabis to their patients.”
Clinical trials, revolutionary permits
As of right now, Santé Cannabis is recruiting patients for two clinical trials – one being a Phase 3 trial for “the investigational inhaled cannabis product PPP001 for the treatment of advanced cancer pain and associated symptoms, the other a Phase 2 study “investigating oral capsules of cannabis oil, PPP005, for the treatment of chronic pain.”
Sponsored by Tetra Bio-Pharma, a “global biopharmaceutical leader” in the clinical research and development of cannabinoid-based drugs, the Phase 3 trial is Health Canada-approved – and Health Canada has issued what is known as a Section 56 exemption that allows Santé Cannabis to “store, dispense and deliver cannabis study packages to patients enrolled in each trial,” the first such exemption granted to a community-based clinic site in Canada.
Both trials are sponsored by Tetra Bio-Pharma, a biopharmaceutical “leader” in the R&D of natural and/or cannabinoid-based prescription drugs.