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.”
About Tetra Bio-Pharma
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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Some statements in this release may contain forward-looking information. All statements, other than of historical fact, that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future (including, without limitation, statements regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by use of the words “may”, “will”, “should”, “continue”, “expect”, “anticipate”, “estimate”, “believe”, “intend”, “plan” or “project” or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company’s ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the inability of the Company to obtain sufficient financing to execute the Company’s business plan; competition; regulation and anticipated and unanticipated costs and delays, the success of the Company’s research and development strategies, including this trial, the ability to obtain orphan drug status, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process, the timing of clinical trials, the timing and outcomes of regulatory or intellectual property decisions and other risks disclosed in the Company’s public disclosure record on file with the relevant securities regulatory authorities. Although the Company has attempted to identify important factors that could cause actual results or events to differ materially from those described in forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. While no definitive documentation has yet been signed by the parties and there is no certainty that such documentation will be signed. The forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.
For further information, please contact Tetra Bio-Pharma Inc.
Robert (Bob) Bechard
Executive Vice President, Corporate Development and Licensing
1-888-764-6322 ext. 226
416-425-9143 ext. 204