Tetra Bio-Pharma Maps Out Cannabinoid Metabolites in Humans Following Inhalation of QIXLEEF
02 April 2020 - 2:00PM
Tetra Bio-Pharma Inc. (“
Tetra” or
the “
Company”) (TSX-V:TBP) (OTCQB:TBPMF), a leader
in cannabinoid-derived drug discovery and development, is pleased
to announce the launch of a study to determine the levels of
cannabinoid metabolites (e.g., 7-COOH-CBD), cannabinoid precursors
(e.g., CBGA) and minor cannabinoids (e.g., CBN) in the plasma of
humans. This study is important to the US Food and Drug
Administration (“FDA”) and Health Canada to define the levels of
these compounds in patients consuming cannabis and Tetra’s inhaled
drugs QIXLEEF and CAUMZ.
Tetra has launched a study to quantify the
levels of cannabinoid metabolites and precursors as well as minor
cannabinoids in the plasma samples of humans that received
QIXLEEF™ in its clinical trials. The bioanalysis of these
human plasma samples will allow Tetra to better understand how THC
and CBD are degraded in humans and how long these compounds remain
in the blood as well as the differences between the two inhalation
routes (smoking vs vaping) of consuming QIXLEEF™.
Since early 2017, Tetra used validated methods
to quantify the levels of CBD, THC and 11-OH-THC in the plasma of
all human subjects that received QIXLEEF and PPP005. Over the last
months, bioanalytical methods were developed and validated to
quantify the amount of cannabinoid precursors, such as THCA, CBDA
and CBGA, minor cannabinoids, including Cannabinol,
Cannabichromene, Cannabigerol, and the metabolites 11-OH-THC and
11-nor-9-carboxy-THC in human samples. The methods are developed in
collaboration with one of Tetra’s partners and in compliance with
the FDA and OECD Principles of Good Laboratory Practices.
Drug development research performed by a
pharmaceutical company revealed that the oral administration of CBD
can induce liver injury in patients. This discovery has led the FDA
to recommend to pharmaceutical companies to study the 7-COOH-CBD
metabolite. In 2019, Tetra had already launched studies to develop
and validate bioanalytical methods to measure cannabinoid
precursors in human plasma. Subsequent to this recommendation from
regulators, Tetra initiated the development and validation of a
bioanalytical method to identify and quantify two major human CBD
metabolites, 7-OH-CBD and 7-COOH-CBD.
The analysis of both metabolites is now an FDA
pre-requisite for the clinical development of all cannabinoid
drugs, including QIXLEEF™ and CAUMZ™. By administration of drugs
through inhalation the drug avoids the first pass metabolism and
could result in lower levels of these CBD metabolites. According to
Dr. Guy Chamberland, CEO and Chief Regulatory Officer of Tetra, "It
is important to understand the levels of these metabolites produced
after consuming phytocannabinoids to be able to develop drugs that
are safe for patients. This data could suggest that inhaling
phytocannabinoids from a well-controlled drug, such as QIXLEEF, is
a safer route of administration for patients and allow Tetra to
expand the scope of indications it targets." He added, "These
methods will also be used to analyse the blood samples of all
patients enrolled in a QIXLEEF™ or CAUMZ™ pivotal trial that is
used for drug registration."
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 and
approved, 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. Could we work in “existing regulatory standards of
safety and clinical evidence for pharmaceutical products”.
For more information
visit: www.tetrabiopharma.com
Source: Tetra Bio-Pharma
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For further information, please contact
Tetra Bio-Pharma Inc.:
Investor Contact:Mr. Pascal NigenAlpha Bronze
LLCPhone: + 1 (646) 255-0433tetra@alphabronze.net
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