Tetra Bio-Pharma Maps Out Cannabinoid Metabolites in Humans Following Inhalation of QIXLEEF
Bioanalytical methods developed and validated for its clinical trials.
Tetra initiates study to quantify phytocannabinoid metabolites and precursors and minor phytocannabinoids in human plasma.
OTTAWA, April 02, 2020 (GLOBE NEWSWIRE) -- 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.:
Mr. Pascal Nigen
Alpha Bronze LLC
Phone: + 1 (646) 255-0433