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Tetra Bio-Pharma Announces Start of the REBORN1(C) Clinical Trial
Tetra Bio-Pharma Announces Start of the REBORN1(C) Clinical Trial.
About this update from Tetra Bio-pharma Inc.
[{"type":"text","content":"First ever Phase 2 clinical trial designed to evaluate the effect of cannabis against an opioid treatmentQIXLEEF™ has the potential to transform the pain marketOTTAWA, ON / ACCESSWIRE / May 6, 2021 / Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX:TBP)(OTCQB:TBPMF)(FRA:JAM1), a leader in cannabinoid-derived drug discovery and development today announced the start of the REBORN1© clinical trial. This trial is designed to evaluate the effect of the Company's inhaled proprietary drug formulation, QIXLEEF™, against immediate release oral morphine sulfate on onset of pain relief in people living with cancer. QIXLEEF™ is a botanical drug product with a "fixed ratio" of THC and CBD and is inhaled through a Class 2 medical device vaporizer.Dr. Guy Chamberland, CEO and CRO of Tetra commented, "Today we recognize an important milestone in advancing the clinical development of this new potential therapeutic for people living with cancer pain. Cancer pain is usually managed with a strong opioid. We believe QIXLEEF™, if proven to be safe and effective, would provide patients with cancer pain a safer treatment option with potentially greater benefits than the current standard of care. QIXLEEF™ may in fact transform the pain market, an area that has been stagnant for many years. Tetra has spent years studying the inhalation of cannabinoids from both synthetic and botanical sources. This research has shown that our investigational new drug, when used with a proprietary medical device, can deliver to patients a reproducible and consistent profile of cannabinoids. The graph below demonstrates the consistency of the inhaled delivery of THC and CBD. We confirm that QIXLEEF™ has arrived in the United States and the trial activities are set to begin."REBORN1© is being conducted in the United States in collaboration with the Hassman Research Institute, a clinical research organization, who will enroll twenty adults living with breakthrough cancer pain (BTcP) and currently taking stable opioid treatment for breakthrough pain. This innovative Phase 2 pilot, proof-of-concept open-label crossover comparison study will assess whether inhaled QIXLEEF™ will control BTcP faster than immediate-release morphine sulfate tablets.About Breakthrough Cancer PainCanc...