Tetra Bio-Pharma Inc (TSX:TBD) (OTCQB:TBPMF), a leader in cannabinoid-derived drug discovery and development, announced Thursday 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, the company noted.
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 versus vaping) of consuming QIXLEEF.
Ontario-based Tetra said it has 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 favoring 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,” said CEO Dr Guy Chamberland in a statement.
“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.”
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