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-PharmaTetra 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.comSource: Tetra Bio-PharmaNeither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this 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, 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.For further information, please contact Tetra Bio-Pharma Inc.:Investor Contact:
Mr. Pascal Nigen
Alpha Bronze LLC
Phone: + 1 (646) 255-0433
[email protected]
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