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Health Canada Gives Green Light to Tetra Bio-Pharma’s Cannabis Vs. Fentanyl Trial
Patient recruitment to begin for landmark research
ORLEANS, Ontario, Aug. 09, 2018 (GLOBE NEWSWIRE) -- Tetra Bio-Pharma Inc., a leader in cannabinoid-based drug discovery and development (TSX VENTURE: TBP) (OTCQB: TBPMF), is pleased to announce that Health Canada has approved its protocol for a clinical trial investigating its PPP001 drug as an alternative to the opioid fentanyl in the management of breakthrough cancer pain. The clinical trial will be conducted by Montreal-based Santé Cannabis, a medical clinic and contract research organization specialized in clinical research for cannabis - based therapies.
The trial will assess the time-to-relief in patients suffering from breakthrough cancer pain. Based on its clinical data, Tetra believes that the pharmacodynamic properties of PPP001 may provide a novel faster acting alternative to the opioid fentanyl. In addition, the time-to-maximal plasma concentrations of THC suggest that PPP001 will provide rapid relief to the patient’s suffering. As a prescription drug with a Drug Identification Number (DIN) PPP001 will be eligible for insurance coverage, making the cannabis-based medication accessible in pharmacies thereby providing much easier access.
The Opioid Crisis
There have been numerous news reports in the North America media highlighting the fact that we are experiencing an opioid crisis. In June, the Canadian government asked drug makers to stop marketing opioids, but for patients suffering from uncontrolled pain, this news does not provide them with an alternative to alleviate their pain.
- There were 41,997 opioid-related deaths in the USA in 2016 contributing to the U.S. President’s declaration that the U.S. is experiencing an opioid crisis.
- 92% of the 3,987 apparent opioid-related deaths in Canada in 2017 were accidental.
- Males make up 76% of these fatalities; more than one-third among those aged 30-39.
- The percentage of these accidental deaths involving fentanyl rose from 55% in 2016 to 72% in 2017.
“Medical cannabis may help reduce the use of drugs like fentanyl for treating breakthrough and chronic pain. However, unrefuted scientific data on its safety and effectiveness that will satisfy regulators, professional groups and insurers is what’s missing,” said Dr. Guy Chamberland, Interim CEO and Chief Scientific Officer of Tetra Bio-Pharma. “Tetra is in the business of providing that evidence which would see our drug PPP001 become a complementary prescription therapy. We’ve taken a pharmaceutical pathway of drug development involving collaborative dialogue with Health Canada and the FDA to bring cannabis and cannabinoid products to market so that physicians, who have been hesitant to recommend it, will have a new, trusted therapeutic option for their patients.”
Cannabis versus Fentanyl Clinical Trial Recruitment
Santé Cannabis will begin recruitment for the clinical trial as of October 2018. More information on eligibility criteria as well as the details and duration of the trial can be obtained by visiting the Santé Cannabis website: www.santecannabis.ca/en/research/cannabis-clinical-trial/ or by calling 514-419-4131 and select English and press 5 to reach the research team.
About Tetra Bio-Pharma
Tetra Bio-Pharma (TSX-V: TBP) (OTCQB: TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a Health Canada approved, and FDA reviewed, clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. The Company has several subsidiaries engaged in the development of an advanced and growing pipeline of Bio Pharmaceuticals, Natural Health and Veterinary Products containing cannabis and other medicinal plant-based elements. With patients at the core of what we do, Tetra Bio-Pharma is focused on providing rigorous scientific validation and safety data required for inclusion into the existing bio pharma industry by regulators, physicians and insurance companies.
For more information visit: www.tetrabiopharma.com
About Santé Cannabis
Established in Montreal, Quebec in 2014, Santé Cannabis is a Centre of Excellence in medical cannabis research, clinical practice and healthcare professional training. Since its inception, Santé Cannabis has provided medical assessment, education, monitoring and follow-up to 5,000 patients referred by more than 2,000 Quebec physicians. Santé Cannabis operates within the guidelines for the authorization of medical cannabis as set out by the Collège des médecins du Québec. As an independently credentialed clinical trial research organization, and with unparalleled clinical experience supporting both patients and healthcare professionals, Santé Cannabis has established itself as a global leader in medical cannabis research. Santé Cannabis is currently conducting a Health Canada approved Phase 3 trial for PPP001 for advanced cancer patients suffering from uncontrolled pain and associated symptoms, as well as a Phase 2 trial for PPP005 investigating the use of oral capsules of cannabis oil for the treatment of chronic pain.
For more information visit: www.santecannabis.ca
Source: Tetra Bio-Pharma
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For further information, please contact Tetra Bio-Pharma Inc.
Robert (Bob) Bechard
Executive Vice President, Corporate Development and Licensing
514-288-8500 ext. 209
416-425-9143 ext. 209