Tetra Bio-Pharma Provides Update on its Neuropathic and Chronic Pain Drug Development Program
February 12 2019 - 6:30AM
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 PainFibromyalgia 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-PharmaTetra 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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Forward-looking statementsSome
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For further information, please contact Tetra Bio-Pharma
Inc.Robert (Bob) Bechard
Executive Vice President, Corporate Development and Licensing
514-817-2514 Investors@tetrabiopharma.com
Media Contact: Carol
LevineCarol.levine@energipr.com1-888-764-6322 ext. 226
Marissa ZantiMarissa.zanti@energipr.com416-425-9143 ext. 204
i Https://
https://www.cdc.gov/arthritis/basics/fibromyalgia.htm
ii MEDTRACK
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