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Significant Discovery Reveals New Antiviral Properties of Tetra Bio-Pharma's Innovative Drug ARDS-003

  • Combining ARDS-003 with antiviral drugs significantly decreased viral replication compared to antiviral treatment alone .

OTTAWA, ON, June 21, 2021 /CNW/ - Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX: TBP) (OTCQB: TBPMF) (FRA: JAM1), a leader in cannabinoid-derived drug discovery and development announced today that its investigational new drug ARDS-003 has been studied in a viral infected organoid model as part of a research collaboration between Targeted Pharmaceuticals ("Targeted") and George Mason University. ARDS-003 is a new patent protected therapeutic developed to treat hyperinflammatory conditions, such as those seen in patients suffering from COVID-19 viral infections and sepsis.

On March 26, 2021, Tetra announced it had entered into an agreement with Targeted Pharmaceuticals to initiate additional studies on its leading drug candidate ARDS-003. As a result, a preliminary study on HIV using the HU-308 molecule, the Active Pharmaceutical Ingredient used in our Covid-19 therapeutic ARDS-003, determined that viral replication is significantly decreased when HU-308 is used in combination with a standard antiviral drug to treat HIV. In other words, it clears the virus significantly better than the standard antiviral drug alone. These results suggest that in addition to immunomodulator properties, ARDS-003 demonstrates strong antiviral effects in humans.

Extracellular vesicles (EVs) play a role in the immune response against viral pathogens and post-infection complications, such as neurodegeneration.  They incorporate and spread both viral and host factors, thereby inducing or inhibiting immune responses towards the viruses via multiple mechanisms.  Studies have shown that EVs are implicated in SARS-CoV-2 infected disease.  EVs have been involved in the transfer of viral receptors to other cells making these cells more susceptible for SARS-CoV-2 infection.  Further, according to the Sepsis Alliance (Viral Infections | Sepsis Alliance), viral infections are a frequent cause of sepsis. 

"Understanding the affect of ARDS-003 on EVs in viral infections is important for guiding the long-term clinical development of Tetra's proprietary asset, particularly since this drug clearly has both anti-inflammatory and antiviral properties.  The neuro-organoid spheres used in this study are like mini brains!  They get infected with the virus thereby allowing us to study our drug without infecting live animals. This has transformed how we conduct research" stated Dr. Guy Chamberland, Chief Executive Officer and Chief Regulatory Officer of Tetra Bio-Pharma. 

On June 16, 2021, Targeted stated in its news release "These studies are significant in that cannabinoids may provide a protective effect by alleviating the pathogenic effects of EVs in HIV-1 and CNS-related infections," commented Dr. Fatah Kashanchi, Professor and Director at the George Mason University's Laboratory of Molecular Virology Lab.  "Our data suggests that certain cannabinoids, such as CBD and THC can act as viral transcription inhibitors, potentially through two independent mechanisms and provide significant reduction in EVs released from infected cells", stated Dr. Kashanchi.  Tetra confirms that this research also included its proprietary investigational drug ARDS-003. 

Dr. Guy Chamberland also stated, "Our partnership with Targeted is allowing us to learn more about the therapeutic potential of our proprietary drug ARDS-003.  Sepsis is a major cause of death worldwide and viral infections contribute to this.  These types of studies are a first of a kind using neuro-organoid spheres.  We believe this partnership will lead to new market opportunities for both corporations as we leverage our cannabinoid inhalation intellectual property as well as that of the ARDS-003 drug."

About Tetra Bio-Pharma
Tetra Bio-Pharma (TSX: TBP) (OTCQB: TBPMF) (FRA:JAM1) is a leader in cannabinoid-derived drug discovery and development with a FDA and a Health Canada cleared clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. Our evidence-based scientific approach has enabled us to develop a pipeline of cannabinoid-based drug products for a range of medical conditions, including pain, inflammation, and oncology. 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 biopharma industry by regulators, physicians and insurance companies.

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About Targeted Pharmaceuticals LLC
Targeted Pharmaceuticals is a clinical-stage pharmaceutical company focused on treatments for oncology and central nervous system disorders.

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About George Mason University
George Mason University is Virginia's largest public research university. Located near Washington, D.C., Mason enrolls more than 37,000 students from 130 countries and all 50 states. The National Center for Biodefense and Infectious Diseases (NCBID) at Mason focuses on host-pathogen interactions using proteomics and nanotechnology as they are applied to diagnostic, therapeutic, and vaccine development. NCBID manages The Biomedical Research Lab (BRL), one of thirteen Regional Biocontainment Laboratories in the U.S. constructed with funding support from the National Institute of Allergy and Infectious Diseases/National Institutes of Health (NIAID/NIH), performing pioneering research of infectious diseases, both emerging and potential bio threat agents.

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About the College of Science
The College of Science at Mason is a leader in scientific discovery creating innovative solutions for the rapidly changing needs of today's world. Mason's College of Science blends traditional science education with sought-after programs in disciplines as diverse as personalized medicine, infectious diseases, geoinformatics, climate dynamics, materials science, astronomy, forensic science, and applied mathematics. The College encourages meaningful education and research at all levels offering innovative undergraduate programs, minors, certificates, and graduate degree opportunities, as well as global, transfer-focused, and online, or hybrid, programs that allow professionals the opportunity to reskill or change careers.

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Forward-looking statements
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.

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