Tetra Bio-Pharma Inc. (“Tetra” or the “Company”) (TSX:TBP)(OTCQB:TBPMF), a leader in cannabinoid-derived drug discovery and development, today announced that it expects government funding to help accelerate its sepsis and acute respiratory distress syndrome (ARDS) drug development.
As the first Endocannabinoid System (ECS) biotechnology company tackling sepsis, a life-threatening condition associated with COVID-19 and other inflammatory conditions including pneumonia and tumors, we were advised that we have been positively recommended for government funding of our drug candidate ARDS-003 for development as a therapeutic to treat sepsis and ARDS.
“This public funding recommendation confirms our diligent and dedicated research in discovering and developing a new drug therapeutic for saving lives and it is a sign of approval by a public agency. Prior to Sars-CoV-2, there were 11 million sepsis-related deaths worldwide¹. With government support we will be optimizing the clinical program to rapidly bring ARDS-003 to the market and tackle this global crisis. Preclinical studies have demonstrated significant anti-inflammatory effects in models of acute sepsis. Our collaborative work with Targeted Pharmaceutical LLC will build on this and allow the joint research teams to study ARDS-003 against other viral induced cytokine release syndrome (CRS) conditions that lead to ARDS and sepsis, such as those caused by Influenza A. This is why we have a 20% ownership in this USA biotechnology company. Tetra’s preclinical group will expand its CRS research to cancer and immunotherapy-induced sepsis and ARDS.” said Dr. Guy Chamberland, CEO and CRO of Tetra Bio-Pharma.
“With government recognition, Tetra will optimize its clinical program to seek a marketing claim for sepsis and ARDS. We will be able to rapidly adjust the clinical program by navigating through the Sars-CoV-2 regulatory paths. Since sepsis and ARDS are life-threatening conditions, the expedited regulatory pathways remain available to ARDS-003 independent of the vaccine campaign success rate,” said Dr. Chamberland.
About the Global Sepsis Market
The World Health Organization (WHO) describes sepsis as a life-threatening multi-organ dysfunction caused by the immune response to an infection. When not treated adequately, it can result in septic shock, multiple organ failure and death¹.
According to the WHO, in 2017 there were 48.9 million cases of sepsis and 11 million sepsis-related deaths worldwide accounting for roughly 20% of all deaths.
About the Cancer Related Sepsis Market
Hospitalization due to infection is a common complication for patients living with cancer. Immunosuppression in cancer patients, resulting from cancer therapy or due to the cancer itself, leads to severe infection, which is a frequent cause of death in these patients. More than 1 in 5 sepsis hospitalizations is cancer-related and is associated with 8.5% of all cancer deaths. In addition, the readmission rate of 30 days after hospitalization is higher after a cancer-related sepsis admission (23.2%) than a non-cancer-related sepsis admission (20.1%). Sepsis and the related exaggerated inflammatory reactions also have a pharmacoeconomic impact on costs of health care of cancer patients².
About the Trauma-Related Sepsis Market
Trauma is a major cause of death in North America and is responsible for approximately six million deaths per year worldwide³. Trauma associated tissue injury triggers an inflammatory response that is required for healing and defense against bacteria and viruses. In addition, the operative procedures promote a pro-inflammatory response. These can become exaggerated leading to SIRS or sepsis and septic complications (e.g., ARDS and MODS). 39.5% of deaths that happen after trauma occur in the hospital⁴. Despite current modern health care, the incidence of mortality associated with post-traumatic sepsis in the hospital remains between 19.5% and 23% of septic trauma patients.
About Tetra Bio-Pharma
Tetra Bio-Pharma (TSX: TBP) (OTCQB: TBPMF), is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a FDA and a Health Canada approved 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.
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