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Tetra Bio-Pharma Provides Update on Research Collaboration with the University of Montreal Hospital Research Centre for Inhaled CBD

  • Health Canada approved the amendment of the phase I study to assess the effect of low and moderate doses of inhaled CBD in healthy cannabinoid users.
  • The collaboration with the CRCHUM will allow Tetra to obtain phase I clinical data on inhaled CBD.

OTTAWA, ON, March 8, 2022 /CNW/ - Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX: TBP) (OTCQB: TBPMF) (FRA: JAM1), a leader in cannabinoid-derived drug discovery and development announced today that Health Canada approved the amendment of a phase I study conducted in collaboration with Dr. Jutras-Aswad and the University of Montreal Hospital Research Centre (Centre de recherche du Centre hospitalier de l'Université de Montréal, ("CRCHUM"). The study will assess the safety profile of low and moderate doses of inhaled CBD and determine the cognitive, behavioral, and biological effects of CBD in adults who occasionally use cannabis. The clinical trial has been authorized by Health Canada, who also recently approved an amendment to the research protocol to increase the dosage of the study drug up to 100 mg of CBD to be assessed in the study.

Under the collaboration, Tetra will supply the synthetic cannabidiol investigational drug products and placebo and in exchange will gain access to clinical data collected in the study. The data will include safety, pharmacokinetic, and pharmacodynamic in humans exposed to Tetra's inhaled CBD product.

Guy Chamberland, CEO and Chief Regulatory Officer of Tetra, commented, "we are very pleased to pursue our collaboration with Dr. Jutras-Aswad and the CRCHUM. Dr. Jutras-Aswad is a reference in cannabinoid research, addiction, and mental health. His research meets a public heath need to better understand the impact of cannabinoid use in human health. Together with Dr. Jutras-Aswad and the CRCHUM, one of the largest biomedical and healthcare research centres in Canada, we will advance clinical research and cannabis science in Canada."

Dr. Jutras-Aswad commented, ''there is an urgent need to accelerate the research effort to provide accurate information about the effects of cannabinoids and cannabis. This study will be critical to clarify the psychological, cognitive, and biological effects of CBD at doses that are commonly used by consumers. The approval from Health Canada is a major step in achieving these goals.''

About the Clinical Trial
The study is a placebo-controlled, triple-blind, cross-over randomized controlled trial (RCT) to evaluate the behavioral and biological effects, as well as the safety of varying doses of inhaled CBD compared to placebo in 80 healthy, adults who occasionally use cannabis. The trial will take place at the CRCHUM in Montreal, Quebec. Participants will be healthy adults between the ages of 21 and 65, who use cannabis occasionally. The study is funded by the Direction générale de la santé publique (DGSP) of Quebec's ministère de la Santé et des Services Sociaux. This clinical study will be conducted in accordance with applicable Health Canada regulations, ICH guidelines on current GCP, and the Declaration of Helsinki. 

About Dr. Didier Jutras-Aswad
Dr. Jutras-Aswad is the Chief of Staff of the Department of Psychiatry at the Centre hospitalier de l'Université de Montréal (CHUM), where he practices as an Addiction Psychiatrist. He is an associate professor at the Université de Montréal (UdeM) and President of UdeM's Centre d'expertise et de collaboration en troubles concomitants. As the principal scientist at the CHUM research centre where his work focuses on cannabis, addiction, and comorbid conditions, particularly mental health disorders, he is regularly consulted by government bodies for questions pertaining to cannabis, substance use, and mental health. He leads clinical trials at the local and national levels, focusing on the development and evaluation of the best interventions and models of care for these conditions. He also developed a dynamic clinical research program to study the effects of cannabinoids administration in humans.

About the CRCHUM
The University of Montreal Hospital Research Centre (CRCHUM) is one of North America's leading hospital research centres. It strives to improve adult health through a research continuum covering such disciplines as the fundamental sciences, clinical research, and public health. Over 2,300 people work at the CRCHUM, including more than 500 researchers and more than 520 graduate students.

For more information: and @CRCHUM

About Tetra Bio-Pharma
Tetra Bio-Pharma (TSX: TBP) (OTCQB: TBPMF) (FRA:JAM1) is a leader in cannabinoid-derived drug discovery and development with a FDA and a Health Canada cleared clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. Their evidence-based scientific approach has enabled them to develop a pipeline of cannabinoid-based drug products for a range of medical conditions, including pain, inflammation, and oncology. With patients at the core of what they do, Tetra Bio-Pharma is focused on providing rigorous scientific validation and safety data required for inclusion into the existing biopharma industry by regulators, physicians and insurance companies.

For more information:

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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 potential acquisitions and financings) 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 Company's research and development strategies, including the success of this product  or any other product, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process, 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.

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SOURCE Tetra Bio-Pharma Inc.

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