Tetra Bio-Pharma Announces Plenitude Clinical Trial is Initiated
Tetra Bio-Pharma Inc. (TSX:TBP) (OTCQB:TBPMF) is a leader in cannabinoid-derived drug discovery and development. The company announces that it has initiated the in-life phase of the clinical trial operations now that the investigational QIXLEEF™ drug has been shipped by Aphria Inc.
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, containing cannabinoid 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.
The Plenitude© trial is designed to prove the efficacy and safety of QIXLEEF™ for the relief of pain in cancer patients. This trial, and its clinical sites across the Unites States, have already received the authorizations from the US Food and Drug Administration (FDA) and the US Drug Enforcement Agency (DEA). Since the authorization from the US FDA in November 2019, Tetra has been working with Aphria Inc. to manufacture sufficient quantities of high quality pharmaceutical GMP grade QIXLEEF™ product according to upgraded specifications on drug product composition as approved by the FDA.
The Plenitude© trial involves ten clinical sites across the United States. Tetra is using a DEA-licensed centralized pharmacy to distribute QIXLEEF™ to the clinical sites and ensure random and double-blind allocation of the product to the patients in accordance with Good Clinical Practices and the USA Food and Drug regulations. With these critical pieces in place, patient recruitment, enrollment and treatment will now begin. Plenitude© is a 4-week double-blind, randomized, placebo-controlled, parallel group design trial to evaluate the safety and efficacy of inhaled QIXLEEF™ to relieve uncontrolled cancer related pain in 78 adult patients with advanced incurable disease.
Dr. Guy Chamberland, CEO and CRO commented, “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. 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. 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.”