Tetra Bio-Pharma Inc (TSE:TBP) (OTCQB:TBPMF) (FRA:JAM1), a leader in cannabinoid-derived drug discovery and development, has announced the start of the REBORN1 clinical trial.
The trial is designed to evaluate the effect of the company's inhaled proprietary drug formulation, QIXLEEF, against an immediate-release oral morphine sulfate on the 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.
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"Today we recognize an important milestone in advancing the clinical development of this new potential therapeutic for people living with cancer pain,” said CEO Dr Guy Chamberland in a statement.
“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."
Dr Chamberland added: “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.”
Tetra said the REBORN1 trial is being conducted in the US in collaboration with the Hassman Research Institute, a clinical research organization, that will enroll 20 adults living with breakthrough cancer pain (BTcP) and currently taking stable opioid treatment for breakthrough pain.
The 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.
The company noted that cancer causes pain in up to 70% of the patients it affects, with over 33% of those patients describing pain as distressing or even intolerable. People with cancer pain may experience persistent background pain (more than 12 hours per day) and episodic acute pains (breakthrough pain) with an overall reduction in their health-related quality of life.
It added that BTcP is defined as "a transient exacerbation of pain that occurs either spontaneously, or in relation to a specific predictable or unpredictable trigger (incident pain), despite relatively stable and adequately controlled background pain."
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