- 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 /PRNewswire/ - 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: www.chumontreal.qc.ca/crchum 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: www.tetrabiopharma.com
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release.
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,
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Forward-looking statements are subject to a number of risks and
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Company to differ materially from those discussed in the
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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
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SOURCE Tetra Bio-Pharma Inc.