Tetra Bio-Pharma Provides Update on its Neuropathic and Chronic Pain Drug Development Program
ORLEANS, Ontario, Feb. 12, 2019 (GLOBE NEWSWIRE) -- Tetra Bio-Pharma Inc. ("Tetra" or the "Corporation") (TSX VENTURE: TBP) (OTCQB: TBPMF), a global leader in cannabinoid-derived drug development and discovery, today announced accelerated development of its second-generation drug inhalation program for fibromyalgia and uncontrolled pain over the last months.
A Phase 1 study in healthy volunteers using vaporized PPP001 was successfully completed (click here) and the Corporation filed a patent application after unexpectedly discovering the unique composition of cannabis smoke. In July 2018, the Corporation entered into a co-development agreement with Storz & Bickel, widely recognized as the global leader in vaporizer design and manufacturing. Tetra incorporated the vaporizer into its smoke-vapor research program as it aimed to understand how inhaled cannabis relieves pain for patients.
About Neuropathic Pain (Fibromyalgia) and Chronic Pain
Fibromyalgia affects about 4 million U.S. adults or about 2% of the adult populationi. The main symptom associated with the condition is the wide range of pain symptoms that can be deep, sharp, dull, throbbing, or aching, affecting the muscles, tendons, and ligaments around the joints throughout the entire body. Treatments aimed at pain relief are the primary treatment intervention including an increasing use of opioids. Chronic pain is also associated with numerous other medical conditions including rheumatoid arthritis, osteoarthritis, gastro intestinal problems, cancer, surgery, HIV/AIDS. The global fibromyalgia treatment market was valued at approximately $10 billion dollars in 2017ii.
Tetra gained knowledge and understanding as to how smoked and vaporized cannabis works to relieve pain, based on its double-blind randomized placebo-controlled studies of PPP001 administered with the titanium pipe and Mighty Medic vaporizer and the use of smoke-vapor trapping studies to quantify exposure to the respiratory tract. A significant finding of the study was learning how much of each cannabinoid and terpene is delivered to the human body as the result of smoking or vaporizing a dried cannabis product. The key to the success of a smoked cannabis product is closely linked to its speed of delivery to the brain. In addition, the inhalation mode of delivery results in significantly higher maximal plasma levels at the peak of treatment. What does this mean? Essentially, results from our study in humans showed that the peak therapeutic levels show only a 1-minute difference in delivery between the pipe and vaporizer. Combined with the speed, the levels of cannabinoids delivered at this peak of exposure are what results in the benefits seen in patients who suffer from pain.
The pipe or vaporizer delivered important differences in some cannabinoids and terpenes. Tetra is using this insight to accelerate the development of alternative formulations for the treatment of fibromyalgia and uncontrolled chronic pain. This knowledge is incorporated in the filed patent application and based on this, Tetra will use isolates or synthetic-based supplies of cannabinoids and terpenes to develop these prescription cannabinoid-derived medicines.
During the last quarter of 2018, the Corporation began preparations for a research site in the United States to conduct its fibromyalgia clinical trial and we are intent on expanding clinical sites in Canada and in the USA in 2019.
We previously communicated that after reviewing the human clinical data, Tetra anticipated proceeding into phase 2 clinical trials in fibromyalgia patients
said Dr. Guy Chamberland, CEO and CSO of Tetra Bio-Pharma.
We are committed to this target and plan to accelerate this development in the USA as well. Tetra has and continues to gain tremendous credibility within the medical community. We earned this credibility because of our clinical studies and exhaustive characterization of the pharmaceutical composition of cannabis-derived smoke and vaporization products. Overall, 2018 was a productive year after completing several clinical trials and we expect 2019 to build on this as we accelerate this program
Tetra Bio-Pharma (TSX-V: TBP) (OTCQB: TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a Health Canada approved, and FDA reviewed, clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. The Company has several subsidiaries engaged in the development of an advanced and growing pipeline of Bio Pharmaceuticals, Natural Health and Veterinary Products containing cannabis and other medicinal plant-based elements. With patients at the core of what we do, Tetra Bio-Pharma is focused on providing rigorous scientific validation and safety data required for inclusion into the existing bio pharma industry by regulators, physicians and insurance companies.
For more information visit: www.tetrabiopharma.com
Source: Tetra Bio-Pharma
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