Tetra Bio-Pharma’s Management Provides Corporate Update on QIXLEEF(TM) & CAUMZ(TM) Drug Development Activities

Tetra Bio-Pharma Inc. (TSXV:TBP)(OTCQB:TBPMF), is a leader in cannabinoid-derived drug discovery and development. The company announces that the long awaited resumption of its PLENITUDE© clinical trial is on time and set to commence in Q3 2020. In addition, the Corporation expects to resume the ReBorn© clinical trial to bring CAUMZ™ to the market as an alternative to opioids for breakthrough pain.
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.
The Plenitude© trial, which will involve ten clinical sites across the United States, is set to begin site initiation study specific procedures in August 2020. This is important to ensure the principal investigator and study staff understand the study protocol, that all the operational steps have been implemented, and that specific roles and responsibilities have been clearly defined and understood by all parties. Patient recruitment and enrollment will begin as soon as the sites receive the GMP grade cannabis drug product from Aphria. Plenitude© is on target to deliver the initial drug dose to patients in the clinical trial by September 2020.
Over the last six months, Tetra has been planning for the manufacturing of CAUMZ™ at an undisclosed site in the USA. This project was initiated as part of Tetra’s risk mitigation framework aimed at reducing delays to export CAUMZ™ to the USA. The Corporation expects to complete the manufacturing set-up and required GMP validations prior to the start of the ReBornã trial. Guy Chamberland, commented, “Once the USA and Canadian manufacturing facilities are fully operational and validated, Tetra will be able to accelerate the clinical development of the CAUMZ™ technology product line. This is also a critical path for completing the regulatory requirements for marketing approval. Subject to the outcome of the metabolite profiling study, which is ongoing, this validated manufacturing process would allow the Corporation to accelerate any CAUMZ™ technology product rapidly for patients.”







