PATHWAY NOW CLEARED FOR HUMAN TRIALS
OTTAWA, ON / ACCESSWIRE / December 2, 2020 / Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX:TBP) (OTCQB:TBPMF), a leader in cannabinoid-derived drug discovery and development, today announced it has completed Investigational New Drug (IND) -enabling toxicology, clearing the way for human clinical trials for its novel drug candidate ARDS-003.
Acute Respiratory Distress Syndrome (ARDS) is a leading cause of death in patients with COVID-19, as well as in other conditions that cause severe respiratory inflammation. Tetra Bio-Pharma's novel drug candidate ARDS-003, is a synthetic cannabinoid-derived therapeutic aimed at preventing and treating the serious and life-threatening inflammatory response that is associated with COVID-19, sepsis, septic shock, and others.
Successful completion of the safety studies is required to submit a Clinical Trial Application in Canada and an IND in the USA for ARDS-003 for a Phase I study in humans. Dr. Guy Chamberland M.Sc., Ph.D., Chief Executive Officer and Chief Regulatory Officer of Tetra Bio-Pharma noted, "This is an exciting and critical step in the development of ARDS-003. As few as 1 out of 1,000 compounds cross this threshold and make it into Phase 1 human trials. Based on the safety data, the medicinal ingredient and the sterile injectable drug product ARDS-003 are both safe for use in humans. With over 12 years of preclinical efficacy research in sepsis and cytokine hyperinflammatory reactions, we are very confident that ARDS-003 will be an efficacious drug. Moreover, this will allow us to address markets with large unmet medical needs in conditions where uncontrolled inflammatory response contributes to mortality."
The toxicology program was designed to meet the international standards established by the International Council for Harmonisation (ICH) for enabling a first-in-human clinical trial and included general toxicology in two species, specific studies to assess toxicity in major organ systems (cardiovascular, respiratory, nervous system) and genotoxicity. Studies investigating the metabolism and kinetics of distribution were also completed.
The toxicology studies were performed in rodent and nonrodent species and include:
- single dose pharmacokinetics;
- maximum tolerated dose;
- 7-day dose range finding; and
- 14-day repeat dose toxicity with toxicokinetics and recovery.
Safety pharmacology and other toxicology studies include:
- cardiovascular study in conscious dogs;
- respiratory system assessment in rodent; and
- central nervous system assessment in rodent.
Genotoxicity assessments include:
- bacterial reverse mutation assay
- in vitro (mammalian cell) micronucleus assay
- in vivo micronucleus assay
- Metabolic profiling;
- cytochrome P450 inhibition and induction;
- microsome and hepatocyte stability (mouse, rat, dog, monkey, human); and
- blood compatibility.
The Company is not making any expressed or implied claims that its product has the ability to eliminate, cure and/or contain the COVID-19 or the SARS-COV-2 virus at this time.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines. For more information, please click here.
About Tetra Bio-Pharma
Tetra Bio-Pharma (TSX:TBP) (OTCQB:TBPMF), is a biopharmaceutical leader in cannabinoid-based drug discovery and development with late-stage clinical development programs in both Canada and the USA aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. Tetra's evidence-based scientific approach has enabled the development of a pipeline of drug products for a range of medical conditions, including pain, inflammation, and oncology. Tetra Bio-Pharma is focused on providing rigorous scientific validation and safety data required for inclusion into the existing biopharma industry by regulators, physicians and insurance companies.
For more information visit: www.tetrabiopharma.com
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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 this product or any other product, 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. 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.:
Tetra Bio-Pharma Inc
Dr. Guy Chamberland, M.Sc., Ph.D.
Chief Executive Officer
Phone: + 1 (833) 977-7575
Alpha Bronze, LLC
Mr. Pascal Nigen
Phone: + 1 (646) 255-0433
Ms. Carol Levine APR, FCPRS
Phone: + 1 (416) 425-9143 ext. 226
Mobile: + 1 (514) 703-0256
SOURCE: Tetra Bio-Pharma