Canntab Enters Into a Binding Term Sheet With Leading Orthopaedic Surgeon Dr. Don Garbuz, M.D. for a Clinical Research Trial of Canntab’s Tablets
December 5th, 2018
- Partnership formed with Dr. Don Garbuz, an award winning orthopaedic surgeon and medical researcher, credited with over 120 peer reviewed publications.
- The parties will seek to conduct a clinical study with orthopaedic patients, using Canntab’s sustained release tablets.
- The study aims to show the potential for reduction or elimination of the use of opiates in patients, a major epidemic throughout North America.
- The study will also seek to show the efficacy of Canntab’s cannabis products for pain management and improvements in patient overall health outcomes.
TORONTO, Dec. 05, 2018 (GLOBE NEWSWIRE) — Canntab Therapeutics Limited (CSE: PILL, FSE: TBF1) (“Canntab” or the “Company”), today announces the launch of a research partnership with world-renowned orthopaedic surgeon, Dr. Don Garbuz, M.D. (Head of the Division of Lower Limb Reconstruction and Oncology of the Department of Orthopaedics at the University of British Columbia), subject to approval of the University of British Columbia where the proposed clinical trial will take place. The aim of the study is to examine and quantify the efficacy of Canntab products in decreasing the duration and quantity of postoperative use of opioid medications and in the management of preoperative pain. Dr. Garbuz shall be the Lead Investigator for the research study.
The Company is seeking approval from UBC to conduct with Dr. Garbuz as lead investigator, a randomized, double-blind, placebo-controlled clinical trials to determine the efficacy of Canntab’s products in helping effectively treat pain in patients. The study will look at the use of Canntab tablets to treat pain after knee replacement surgery. Patient safety and tolerability will also be assessed. Further, Canntab’s patent pending filing for addiction treatment therapy for opioids and other painkillers, and its specific proprietary tablet formulation, will be the starting point for the dosing delivery mechanism to be used in the study.
Canntab advises that it will create the tablets for the study in Coburg, Ontario with FSD Pharma, a Licensed Producer under the ACMPR in furtherance of their collaboration and license agreement dated September 17, 2018.
Zeeshan Saeed, President and Founder of FSD Pharma commented, “We are pleased that Canntab will be producing its tablets for this important study at our facility in Cobourg. The aim of this work is clearly in line with FSD Pharma’s direction and plans to develop pharmaceutical cannabinoid-based treatments for pain to counter the opioid crisis, including opioid abuse, dependence and overdose.”
Dr. Don Garbuz will be overseeing the study as lead investigator pursuant to a consulting agreement to be entered into between Canntab and Dr. Garbuz. Dr. Garbuz is a renowned orthopaedic surgeon and medical researcher, a Professor at the University of British Columbia and is credited with over 120 peer reviewed publications. Dr. Garbuz has been awarded the Hip Society Award for Best Research Paper four times; in 2009, 2011, 2013 and 2017.
“I am excited to be partnering with Canntab to look at conducting a trial that will analyze the efficacy of cannabis as a replacement for opioids, in postoperative care of orthopedic surgical patients undergoing hip/knee replacements at the UBC Hospital. This study will help advance our understanding of the potential effects of cannabis as a treatment for pain and will become the basis for conducting future cannabinoid and pain management clinical trials,” said Dr. Don Garbuz, M.D. “This important study which aims to help us better understand the potential impact of cannabis as an alternative for opioids, so that patients might face better outcomes.”
There is an opioid epidemic in the United States and Canada. The quality of life and addiction issues that stem from the widespread use of opioids is a major concern for individuals, communities, health care professionals and all levels of government. Most, if not all, patients undergoing total knee and hip arthroplasty use opioid medication to control their pain postoperatively. Their opioid usage is proving to be detrimental to overall health outcomes in some patients, and sometimes fatal. It is not uncommon for patients to misuse these medications after surgery, with nearly 5% of previously opiate-naïve patients becoming chronic abusers. A study from The Centers for Disease Control and Prevention (CDC) found that opiate prescriptions with medication supplies lasting greater than 8 days increased the likelihood of long-term abuse at 1 year (references below).
The financial arrangement calls for an initial upfront fee to create the clinical protocol while securing the participation and, required approvals of the clinical trial by UBC and the independent team comprising the Ethics Committee. Following those approvals, funds will be disbursed partially on certain milestones being achieved. The total cost of the study is estimated at approximately $600,000 with an anticipated time frame to complete of between 12 to 18 months.
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