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Tetra Bio-Pharma Announces Drug Candidate as Potential Therapy for Managing Cytokine Release Syndrome

04/27/2020

Preclinical proof of concept of PPP003 as potential drug candidate for sepsis demonstrated
Tetra to develop PPP003 as potential drug therapy for the battle against COVID-19

OTTAWA, ON / ACCESSWIRE / April 27, 2020 / Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX-V:TBP)(OTCQB:TBPMF), a leader in cannabinoid-derived drug discovery and development, is pleased to announce it is adding a new indication in the development of PPP003.

Panag Pharma's (Panag), a subsidiary of Tetra, PPP003 is a synthetic cannabinoid drug that selectively acts at the type 2 cannabinoid receptor (CB2R). "Panag's scientific team and academic collaborators have been studying the role of the CB2R in acute immune responses for over a decade. The active molecule in PPP003 can reduce inflammation and dampen pro-inflammatory cytokine release, therefore, PPP003 should be carefully examined as a candidate drug to help reduce symptoms of acute lung inflammation and immune system dysregulation in those SARS-CoV-2 patients at risk", states Tetra's CSO, Dr. Melanie Kelly, Ph.D.

Guy Chamberland, CEO & CRO of Tetra commented, "It is a time for all pharmaceutical companies to contribute to the management of COVID-19 patients. We agree with our Canadian political leaders this is a time of national emergency. Our Panag team has been performing research on the prevention and management of severe systemic immune dysregulation such as sepsis since the early 2000s. One of their founders, Dr. Christian Lehmann, has published multiple articles on the CB2R and its role in cytokine storm related to sepsis as well as the role of agonists of CB2R as potential treatment. These articles appear in peer reviewed scientific journals. This research also focused on the active molecule of Tetra's drug known as PPP003."

Acute Respiratory Distress Syndrome (ARDS) is observed in approximately 10-15% of patients with COVID-19. It is triggered by massive cytokine release termed cytokine release syndrome (CRS) or cytokine storm. Drugs that can prevent or decrease the severity of ARDS may potentially result in an improved clinical outcome of this group of patients with the highest mortality. In fact, early CRS treatment might be able to avoid severe courses of COVID-19 such as ARDS.

"Cannabinoids that act at CB2R have shown promise for reducing the acute inflammatory response in experimental sepsis and some of these could be useful in patients with SARS-CoV-2. Evaluating Tetra's PPP003 drug in well-designed clinical trials is essential to identify candidate drugs that can help to prevent progression of symptoms of the acute lung injury and heightened immune response seen in some patients following SARS-CoV-2 infection" (Dr. Christian Lehmann, M.D. Ph.D. FRCPC, Panag Pharma co-founder and Professor, Department of Anesthesia, Pain Management & Perioperative Medicine, Department of Microbiology & Immunology, Department of Physiology and Biophysics, Department of Pharmacology, Dalhousie University).

Panag has already completed preclinical efficacy and proof of concept studies in sepsis. Taking this new drug into human trials only requires finishing the IND-enabling toxicology studies. Tetra has already initiated several programs to develop PPP003 as a prescription drug. In fact, this active molecule is already fabricated under sterile cGMP conditions for its ophthalmic veterinary and human drug development programs. The entire, ongoing, nonclinical safety program and Phase 1 human safety trial for PPP003 is part of its 2020 budget for the ophthalmic program. "Hence, accelerating this program to potentially bring a new drug candidate to physicians battling COVID-19 is without financial risk to the corporation", commented Dr. Chamberland.

Tetra will be applying for the research funds announced last week by Prime Minister Justin Trudeau. If granted, these funds would be used to finance part of the clinical program that will be used to demonstrate the safety and efficacy of these drugs. Tetra will be advancing this program in both Canada and the USA. Dr. Chamberland added, "targeting patients with COVID-19 in the hope of preventing a cytokine release syndrome that leads to ARDS will be our primary focus. Due to the importance of this program to Canadians, Tetra shall provide frequent updates to ensure shareholders are aware of all advancements."

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 approved, and FDA reviewed and approved, clinical program 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

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

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 any 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.:

Investor Contact:

Alpha Bronze, LLC
Mr. Pascal Nigen
Phone: + 1 (646) 255-0433
tetra@alphabronze.net

Media Contact:

Energi Pr Inc.
Ms. Carol Levine APR, FCPRS
Phone: + 1 (416) 425-9143 ext. 226
Mobile: + 1 (514) 703-0256
carol.levine@energipr.com

SOURCE: Tetra Bio-Pharma



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