Tetra Bio-Pharma and Santé Cannabis Announce Completion of the First Phase 2 Cannabis Oil Trial in Cancer and Non-Cancer Patients
OTTAWA, March 04, 2019 (GLOBE NEWSWIRE) -- Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX-V: TBP) (OTCQB: TBPMF), a global leader in cannabinoid-derived drug development and discovery, is pleased to announce completion of the first double-blind, randomized and placebo-controlled Phase 2 clinical trial of cannabis oil capsules. The trial evaluated the safety and efficacy of different doses and ratios of medical cannabis oil comprised of THC and CBD, for the treatment of uncontrolled chronic pain in cancer and non-cancer patients.
The Phase 2 trial was conducted by Montreal-based Santé Cannabis, Quebec's first clinical research organization specializing in cannabis and cannabinoids for medical purposes. Dr. Antonio Vigano, and his colleagues at Santé Cannabis, designed this study to obtain clinical data on the safety and potential efficacy of various cannabis oils used in the practice of medicine under the Cannabis regulations.
During the next 3 months, Santé Cannabis will study the data and submit a scientific manuscript for publication addressing key outcomes from the trial:
- Safety and tolerability data, such as side effects, associated with the approach used in this study;
- Preliminary efficacy data on the three different ratios of THC and CBD used; and
- Preliminary data on the minimal effective dose of each cannabis oil.
This study will provide evidence-based data on medical cannabis for chronic pain
said Dr. Antonio Vigano, Research Director of Santé Cannabis and McGill University Associate Professor in the Department of Oncology.
For many patients, under careful monitoring, cannabis oil can potentially reduce or even eliminate the need for other pharmacological medications. The outcome of this study will support clinicians to better understand dosing and titration of medical cannabis in cancer and non-cancer patients. Our data will encourage researchers to pursue deeper studies to quantify real benefits and potential risks of natural cannabinoids as a complementary therapeutic approach across larger populations
According to Dr. Guy Chamberland, Tetra's CEO and CSO,
This study is the first to investigate encapsulated medical cannabis oil for the management of chronic pain. The analysis of key outcomes will provide Tetra Bio-Pharma with important scientific data on the optimal effective dose range for patients suffering from these conditions. We are pleased to continue to support university-based studies such as this, which will help guide some of Tetra’s key drug development programs in chronic pain, oncology and ophthalmic. The Corporation is dedicated to developing prescription cannabinoid-derived drugs for the treatment of uncontrolled cancer and non-cancer pain and to reduce the need for opioids
Tetra Bio-Pharma (TSX-V: TBP) (OTCQB: TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a Health Canada authorized, and FDA reviewed, clinical trials 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
Source: Tetra Bio-Pharma
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