Tetra Bio-Pharma Announces Data on its CBD Metabolite Study in Humans

Tetra Bio-Pharma Inc. (TSX:TBP)(OTCQB:TBPMF) is a leader in cannabinoid-derived drug discovery and development. The company announces 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.

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™.

Tetra Bio-Pharma 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.

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.