Tetra Bio-Pharma Announces Data on its CBD Metabolite Study in Humans
Tetra Bio-Pharma has announced the successful mapping of CBD metabolites in humans after vaporization of QIXLEEF™, a therapy for uncontrolled pain in cancer patients. This study is crucial for regulatory approvals from the FDA and Health Canada. Findings indicated that the inhalation method results in lower levels of harmful metabolites, promoting a safety advantage over oral intake. The data suggest that QIXLEEF™ achieves rapid absorption and efficacy with fewer side effects, positioning it as a preferable option for patients in need of pain relief.
- Successful mapping of CBD metabolites enhances safety profile of QIXLEEF™.
- Demonstrated low levels of harmful metabolites (7-OH-CBD, 7-COOH-CBD) following inhalation.
- Rapid absorption and high efficacy of QIXLEEF™ compared to oral administration.
- None.
- Tetra defines CBD Metabolism in Humans Following QIXLEEF™ Inhalation
- Data from metabolite study provides explanation for inhalation as a safe route of administration
OTTAWA, ON / ACCESSWIRE / August 27, 2020 / Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX:TBP)(OTCQB:TBPMF), a leader in cannabinoid-derived drug discovery and development, today announced that it has mapped out CBD metabolites in humans who were administered QIXLEEF™ by vaporization. QIXLEEF™ is Tetra's first-generation therapeutic for treating uncontrolled pain in advanced cancer patients.
Defining THC and CBD metabolites in human plasma is a critical step for the US Food and Drug Administration and Health Canada to characterize the safety profile of the drug product in patients consuming cannabis. As previously announced, Tetra had launched a study to quantify the levels of cannabinoid metabolites and precursors as well as minor cannabinoids in the plasma samples of individuals who 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™.
Tetra successfully developed and validated methods to characterize the major CBD metabolites (7-OH-CBD and 7-COOH-CBD) in humans, which are known to induce liver injury above a certain threshold of circulating plasma levels. The data demonstrated that the degradation of CBD during QIXLEEF™ inhalation leads to very low amounts of 7-OH-CBD and 7-COOH CBD and a faster degradation profile compared to oral administration.
These data emphasize the benefits of QIXLEEF™ as an inhaled cannabis-based drug. QIXLEEF™ not only has a safe and well tolerated profile, but also has a rapid and high degree of absorption favouring a higher efficacy at a lower dose, compared to oral administration.
"The rapid and relatively high absorption of CBD and the low amounts of CBD metabolites in humans support our claim that inhalation provides a superior safety profile for CBD administration over oral administration. The efficiency of QIXLEEF™ absorption combined with its greater safety profile will offer a unique solution to patients seeking relief from pain due to various diseases and illnesses", said Dr. Guy Chamberland, Tetra CEO and CRO.
About QIXLEEF™
QIXLEEF™, first-generation therapeutic for treating uncontrolled pain in advanced cancer patients is a dried cannabis flower bud derived therapeutic that contains no excipients or other nonmedicinal ingredients. PLENITUDE© is the Company's clinical trial for its investigational therapeutic QIXLEEF™. The second-generation cannabinoid therapeutic, a cannabinoid synthetic version of QIXLEEF™, is called CAUMZ™.
About Tetra Bio-Pharma
Tetra Bio-Pharma (TSX: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.
For more information visit: www.tetrabiopharma.com
Neither 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:
Tetra Bio-Pharma Inc
Dr. Guy Chamberland, M.Sc., Ph.D.
Chief Executive Officer
Phone: + 1 (833) 977-7575
investors@tetrabiopharma.com
Alpha Bronze, LLC
Mr. Pascal Nigen
Phone: + 1 (646) 255-0433
tetra@alphabronze.net
Media Contact:
energi PR
Ms. Carol Levine APR, FCPRS
Phone: + 1 (416) 425-9143 ext. 226
Mobile: + 1 (514) 703-0256
carol.levine@energipr.com
SOURCE: Tetra Bio-Pharma
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