OTTAWA, May 30, 2019 (GLOBE NEWSWIRE) — 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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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 the success of CAUMZ and its other drug candidates, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process including the applications for Orphan Drug Designation, 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. 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.
Tetra Bio-Pharma Contact:
Senior Vice-President, Marketing and Medical Affairs
Jennifer McCaughey, CFA
Vice-President, Investor relations
514-731-0000 ext. 229
Carol Levine, APR, FCPRS
514-288-8500 ext. 226
Source: Tetra Bio-Pharma Inc