Tetra Corporate Update on QIXLEEF(TM) & CAUMZ(TM - Resumption of its PLENITUDE© clinical trial on-time;
- CAUMZ™ manufacturing set to begin in USA to allow start of clinical trials;
- QIXLEEF™ metabolite mapping study to be complete in Q3 2020
OTTAWA / ACCESSWIRE / July 28, 2020 / Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSXV:TBP)(OTCQB:TBPMF), a leader in cannabinoid-derived drug discovery and development, today announced 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.
QIXLEEF™ UPDATE
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.
QIXLEEF™ CANNABINOID METABOLIC PROFILE STUDY IN HUMANS:
On April 2, 2020, Tetra announced the launch of a study to map out the levels of cannabinoid metabolites (e.g., 7-COOH-CBD), cannabinoid precursors (e.g., CBGA) and minor cannabinoids (e.g., CBN) in the plasma of humans that had smoked or vaporized QIXLEEF™. This study is advancing as planned and we expect to receive the first data by end of August, beginning of September. Tetra is on track to complete this study as promised in Q3 2020. Dr. Guy Chamberland, CEO and CRO of Tetra commented, "We look forward to the 7-COOH-CBD metabolite data as the levels of this metabolite could provide an explanation of the recognized safety profile for the inhalation route of administration of the drug product through the Mighty Medic device, relative to the oral dosing route. If this is the case, Tetra believes that its inhalation technology could provide a safer solution to avoid liver toxicity in patients seeking CBD-based therapies."
CAUMZ™ UPDATE:
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 ReBorn 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."