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Tetra Bio-Pharma Inc
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Tetra Bio-Pharma increases Plenitude enrolment

2021-05-11 09:06 ET - News Release

Dr. Guy Chamberland reports


Tetra Bio-Pharma Inc. has accelerated a revolutionary phase 2 clinical trial, Plenitude, to evaluate the safety and efficacy of the investigational cannabis medicine, Qixleef, for use in managing uncontrolled pain in patients with advanced cancer.

Qixleef is the company's inhaled proprietary drug formulation which has a fixed ratio of THC (tetrahydrocannabinol) and CBD (cannabidiol). The medication is inhaled through a Class II medical vaporizer. When pharmaceutical-grade cannabis is vaporized rather than smoked, the beneficial components can be inhaled without the generation of smoke and combusted byproducts.

Dr. Guy Chamberland, chief executive officer and chief revenue officer, comments: "The Plenitude study has been under way for many months and we are now accelerating its enrolment activities. Tetra currently has two phase 2 clinical trials ongoing in the United States. Though both trials, Plenitude and Reborn1, will evaluate Qixleef, each has a very different objective. The Plenitude trial will assess how Qixleef may manage uncontrolled cancer pain in patients living with advanced cancer and the Reborn1 trial is a head-to-head study against an opioid treatment in the management of short and frequent episodes of incapacitating pain requesting immediate release opioid treatment in cancer patients. We believe based on our years of research that Qixleef will be proven to be safe and effective and, if so, provide patients with cancer pain a safer treatment option with potentially greater benefits than the current standard of care."

The Plenitude trial is a four-week randomized, double-blind, placebo-controlled study, has been reviewed by an ethics committee and follows good clinical practices. Patients will receive four weeks of either the study treatment or a placebo, after which all patients will be eligible to receive the active study drug for up to an additional 48 weeks. Pain levels will be measured throughout the course of the study to determine the efficacy of the study medication.

Dr. Sue Sisley, medical expert and principal investigator, states: "The goal of the Plenitude study is to help patients with advanced cancer manage their pain to improve their overall quality of life. I am excited about this study because it offers hope to patients who experience severe pain. Many patients have difficulty tolerating powerful therapies, like opioids. I am encouraged because cannabis has been long considered a low-risk option for patients with cancer with few and tolerable side effects. Together we may discover a new treatment option for managing pain!"

About advanced cancer pain

Advanced cancer pain is defined by the International Association for the Study of Pain as "unpleasant sensory and emotional experience associated with actual or potential tissue damage." Pain is a common symptom associated with a cancer diagnosis. Market studies performed on behalf of Tetra for advanced cancer pain in the United States estimate that the addressable market will be worth over $900-million (U.S.) by 2030. This figure takes in consideration the off-label market, which will continue to demand non-opioid treatments.

About Dr. Sisley, MD

Dr. Sisley is an Arizona-based physician practicing internal medicine and psychiatry. She is president of Scottsdale Research Institute, a company which co-ordinates rigorous, scientific studies to assess the safety and efficacy of cannabis and cannabis compounds for treating medical conditions. Dr. Sisley is committed to evaluating the use of pharmaceutical grade cannabis to treat chronic pain, opioid dependence and posttraumatic stress disorder as a safer alternative to synthetic pharmaceuticals.

About Tetra Bio-Pharma Inc.

Tetra Bio-Pharma is a leader in cannabinoid-derived drug discovery and development with a Food and Drug Administration- and a Health Canada-cleared clinical program 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 it 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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