Aphria Inc. has finished the production of its cancer pain drug, QIXLEEF, which has now been shipped to Tetra Bio-Pharma Inc. for the first part of an in-life trial, announced Tetra on Wednesday. This is a cannabidiol (CBD)-based drug that the company has been working on for the past year and the trial, known as Plenitude, will test how effective and safe this inhaled medication is in relieving pain in cancer patients. A total of 78 cancer patients are participating in this trial after the US Food & Drug Administration (FDA) gave its approval back in November.
Tetra has been working alongside Aphria to produce enough quantities of this GMP-graded, high-quality medication since the FDA greenlighted the project. For the clinical trial, Plenitude will take place at ten different sites across the country and, for the distribution of the medication, the company will use a US Drug Enforcement Agency (DEA)-licensed pharmacy. The trial will be a double-blind, randomized, placebo-controlled, parallel-group of patients who receive a cancer diagnosis that is now advanced and incurable.
“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 products for patients with a plant-based drug has been overcome.”
Tetra, based in Ontario, said that it was able to develop and validate methods that allow the company to recognize and control the major CBD metabolites (7-OH-CBD and 7-COOH-CBD) in humans, which are already known to lead to liver injuries that can occur after reaching a certain threshold of circulating plasma levels. “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.