Momentum Public Relations
Press Releases: May 30th, 2019
Tetra Bio-Pharma Inc. (“Tetra” or the “Company”), a leader in cannabinoid-based drug discovery and development (TSX VENTURE: TBP) (OTCQB: TBPMF), will present key findings from its three Phase 1 and its Phase 2 cancer and non cancer investigational trials with cannabinoids, before the Food and Drug Administration’s (FDA) Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds, Part 15 Public Hearing on Friday, May 31, 2019. The meeting will take place in Silver Spring, Maryland.
The goal of the hearing is to obtain additional scientific data and other information related to cannabis and cannabis-derived compounds to inform the FDA’s regulatory oversight of these products. This hearing is particularly important considering the passage of the Agriculture Improvement Act of 2018, Public Law 115-334 (so called Farm Bill), which, among other things, removed the plant Cannabis sativa L. or “hemp” from the Controlled Substances Act. Given the lack of safety evidence in the published literature, the FDA will hear from important stakeholders including patients, academia, manufacturing, retailers, public health and government bodies who will contribute by providing their data and experience. More than 400 different groups and entities made requests to present before the hearing.
Tetra’s presentation will be made by Rola Mazloum, Director of Regulatory Affairs and will comprise but not be limited to the following:
- Demonstrate that:
- inhalation via smoke or vapor achieves significantly superior delivery to the patient than the oral or sublingual routes;
- the oral route with capsules achieves less absorption than that of sublingual delivery;
- Provide a comparison of:
- side effects when given single dose versus repeat daily dosing.
- smoked versus vaped product;
- Present pertinent safety findings from the Phase 1 trials;
- Provide data that suggests a mechanism of tolerance to side effects;
- Present the impact of dose titration comparing smoked versus oral;
- Summarize the mycotoxin (fungi impurities) findings and how Tetra now manages this issue.
“The ground-breaking research that Tetra has and continues to advance is critical in adding to the scientific safety and efficacy data that regulators like the FDA, Health Canada and the European Medical Authority are looking for,” said Dr. Guy Chamberland, CEO and CSO of Tetra Bio Pharma. “Tetra is clearly seen as a world-class leader in conducting robust clinical studies, namely SERENITY© (Phase 3 in advanced cancer pain), REBORN© (phase 2 in breakthrough pain), OPIOSPARE© (Phase 2 to document opioid sparing effect) and others with cannabinoid-derived products to address unmet medical needs. We are privileged to share our insights and add to the body of evidence.”
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 authorized, and FDA reviewed, clinical trials 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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