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Tetra Bio-Pharma trumpets launch of cancer pain relief trial for CBD-based QIXLEEF

Published: 09:25 02 Sep 2020 EDT

Medical professional on a couch with an elderly person
Plenitude is a four-week double-blind, randomized, placebo-controlled, parallel group design trial of 78 adult patients with advanced incurable disease

Tetra Bio-Pharma Inc (TSE:TBP) (OTCQB:TBPMF) announced Wednesday that the in-life phase of a trial of its CBD-based cancer pain drug QIXLEEF has begun after the drug was shipped by its producer Aphria Inc.

The trial, known as Plenitude, will test the efficacy and safety of inhaled QIXLEEF for the relief of pain in 78 cancer patients. Since getting the nod from the US Food & Drug Administration (FDA) in November, Tetra has been working with Aphria to manufacture sufficient quantities of high-quality pharmaceutical GMP grade QIXLEEF.

The Plenitude trial will take place at 10 clinical sites in the US and utilize a US Drug Enforcement Agency-licensed pharmacy for distribution. It is a four-week double-blind, randomized, placebo-controlled, parallel group design trial of 78 adult patients with advanced incurable disease.

READ: Tetra Bio-Pharma maps out CBD metabolites in humans who vaped QIXLEEF therapeutic

“Last week we announced the significantly lower levels of CBD metabolites and today we are pleased to announce that QIXLEEF has been shipped by Aphria Inc,” Tetra CEO Guy Chamberland said in a statement. “The Plenitude trial has been anticipated for a long time and we are proud that the challenge of ensuring high-quality pharmaceutical grade GMP product for patients with a plant-based drug has been overcome.”

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.

“Now, with last week's data, we are confident that we will not have any drug-related liver injury events in the trial. This is a major scientific milestone as it addresses the safety of vaporized QIXLEEF after the discouraging liver injury safety results observed in oral CBD trials for the treatment of seizures,” the group said.

Contact Andrew Kessel at andrew.kessel@proactiveinvestors.com

Follow him on Twitter @andrew_kessel

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