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.”

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 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.

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Source: Tetra Bio-Pharma

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Forward-looking statements

Some statements in this release may contain forward-looking information. All statements, other than of historical fact, that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future (including, without limitation, statements regarding: the anticipated benefits of the Proposed Transaction for Tetra; completion and expected timing of the Proposed Transaction; whether the terms of the Proposed Transaction will be as described in this press release; whether the Proposed Transaction will be successful; the receipt of required regulatory approvals (including stock exchange) in respect of the Proposed Transaction)are forward-looking statements. Forward-looking statements are generally identifiable by use of the words "may", "will", "should", "continue", "expect", "anticipate", "estimate", "believe", "intend", "plan" or "project" or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company's ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the inability of the Company to obtain sufficient financing to execute the Company's business plan; competition; regulation and anticipated and unanticipated costs and delays, the success of the product mentioned in this release, the success of the Company's research and development strategies, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process including the applications for Orphan Drug Designation, the timing of clinical trials, the timing and outcomes of regulatory or intellectual property decisions and other risks disclosed in the Company's public disclosure record on file with the relevant securities regulatory authorities. Although the Company has attempted to identify important factors that could cause actual results or events to differ materially from those described in forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. The forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.

For further information, please contact Tetra Bio-Pharma Inc.

Robert (Bob) Bechard                                     

Executive Vice President, Corporate Development and Licensing

514-817-2514

       

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