Dr. Guy Chamberland reports
TETRA BIO-PHARMA ANNOUNCES START OF THE REBORN1 CLINICAL TRIAL
Tetra Bio-Pharma Inc. has started 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 sulphate on onset of pain relief in people living with cancer. QIXLEEF is a botanical drug product with a fixed ratio of THC (tetrahydrocannabinol) and CBD (cannabidiol) and is inhaled through a Class 2 medical device vaporizer.
Dr. Guy Chamberland, chief executive officer and chief research officer 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. [A graph] 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, which will enroll 20 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 sulphate tablets.
About breakthrough cancer pain
Cancer causes pain in up to 70 per cent of the patients it affects, with over 33 per cent 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 (Zeppetella and Davies, 2013).
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 (Davies et al., 2009). The company's goal is to decrease and manage this pain and improve the overall quality of life for people with cancer pain.
About Tetra Bio-Pharma Inc.
Tetra Bio-Pharma is a leader in cannabinoid-derived drug discovery and development with a clinical program (cleared by the U.S. Food and Drug Administration and Health Canada) aimed at bringing novel prescription drugs and treatments to patients and their health care providers. The company's evidence-based scientific approach has enabled it to develop a pipeline of cannabinoid-based drug products for a range of medical conditions, including pain, inflammation and oncology. With patients at the core of what the company does, Tetra Bio-Pharma is focused on providing rigorous scientific validation and safety data required for inclusion into the existing biopharma industry by regulators, physicians and insurance companies.
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