Ottawa, ON / Business Wire / March 17, 2020 / – Avivagen Inc. (TSXV:VIV) (“Avivagen”), a life sciences corporation focused on developing and commercializing products that safely support immune function and dampen inflammation, thereby supporting general health and well-being, announces today that it is accelerating its plans for commercial launch of its OxC-Beta product as a supplement for human use in response to the COVID-19 pandemic. OxC-beta is a patent protected product that first launched commercially in livestock applications to help remove antibiotics as growth promoters from the food chain, subsequently launched in the companion animal market as a supplement and is now being readied to launch in the US market, initially, for human use as a health supplement. We will provide updates through additional press releases as the product gets closer to an official commercial launch date and product availability.

On March 11, 2020, the World Health Organization declared the COVID-19 outbreak a global pandemic and there has now been significant reporting of the symptoms and viral progression for those infected with COVID-19. Avivagen has been closely studying the transmission of COVID-19, the symptoms and progression and has examined those findings against its own growing body of scientific, fundamental work for how Avivagen’s OxC-beta works, mechanistically, to support innate immune function in various settings.

The earliest stages of the battle between a host and an invading pathogen is fought by the innate immune system. Avivagen’s published work in peer reviewed journals together with unpublished proof-of-concept studies shows that its OxC-beta product supports and primes the innate immune system while also dampening chronic, overzealous inflammatory responses, elements that could prove beneficial to those with heightened risk of infection with COVID-19, seasonal flu, the common cold, and future emerging diseases caused by novel pathogens.

Avivagen has shown that its OxC-beta product boosts the innate immune system by augmenting surveillance through an increase in the number of pathogen sensing receptors, including toll-like receptor-2 and 4 (TLR-2 and 4), that are on the lookout for harmful pathogens1)PLoS ONE, Johnston JB et al, Biologically Active Polymers from Spontaneous Carotenoid Oxidation: A New Frontier in
Carotenoid Activity, 2014.
. Of particular interest, the TLR-2 and TLR-4 pathways, best known for their roles in recognizing bacteria, have also been implicated in the innate immune response to several coronaviruses including Severe Acute Respiratory Syndrome Virus, Porcine Epidemic Diarrhea Virus, and Mouse Hepatitis Virus Type 1.2)mBio, Totura AL et al, Toll-like Receptor 3 Signaling Via TRIF Contributes to a Protective Innate Immune Response To Severe Acute Respiratory Syndrome Coronavirus Infection, 2015.3)Journal of General Virology, Cao L et al, Porcine Epidemic Diarrhea Virus Infection Induces NF-kB Activation Through the TLR2, TLR3 and TLR9 Pathways in Porcine Intestinal Epithelial Cells, 2015.4)Journal of Virology, Khanolkar A et al, Toll-Like Receptor 4 Deficiency Increases Disease and Mortality after Mouse Hepatitis Virus Type I Infection of Susceptible C3H Mice, 2009.

Collateral damage to the host caused by chronic or overzealous inflammation is also a significant factor in determining disease outcomes. Avivagen’s OxC-beta also can decrease chronic inflammation and limit the potential for overzealous inflammatory responses by actively reducing the level of cytokines and chemokines whose dysregulation is known to play a central role in perpetuating harmful inflammation5)Unpublished proof-of-principle results .

Specific examples of work studying OxC-beta that suggest it could be helpful in COVID-19 or other conditions, include a study in a model of bovine respiratory disease (Mannheimia haemolytica challenge), which can cause respiratory failure and death in calves. This study showed that the treatment with OxC-beta of Holstein calves prevented the commonly observed overzealous and harmful inflammatory response by promoting resolution of inflammation in the lungs of these subjects6)American Journal of Veterinary Research, Duquette et al, Anti-inflammatory effects of retinoids and carotenoid derivatives on caspase-3–dependent apoptosis and efferocytosis of bovine neutrophils, 2014. .

Avivagen’s CEO, Mr. Kym Anthony, stated, “We have established a highly compelling body of work for our initial product launches into animal markets, which are gaining traction based on high quality science and consistent results. We believe this same body of fundamental, scientific work also supports our decision to pursue the launch of our product as a health supplement to support optimal immune function while also dampening chronic and potentially damaging inflammatory effects. The seriousness of the COVID-19 pandemic tells us that we have a duty to bring our product forward to try and assist in the global fight to contain the spread of and impact of COVID-19. Longer term, we know that the benefits of our patent-protected OxC-beta product will help countless people face daily challenges by having a primed innate immune system ready to fight pathogens and helping keep undesirable inflammation at bay.”

The product attributes of OxC-beta as a health support product are reinforced by compelling  science that has shown that it works in multiple ways, each reinforcing the reasons to pursue the launch of this product for human use.

With respect to the priming of the innate immune system and having it being at the ready to detect pathogens and eliminate them through the immune system, OxC-beta has been shown to have a multi-fold increase in the expression of the IFNGR1/CD119, TLR2, TLR4, CD14, and LY96/MD2 genes involved in pathogen defence6. Of special note, levels of Toll-like receptors (TLRs), which are recognition molecules for multiple pathogens, including bacteria, viruses, fungi, and parasites, have been shown to be increased in the gut of mice given OxC-beta orally1.

With respect to inflammation, OxC-beta has been shown to have a multifold increase in CD55/DAF gene expression, while having a multifold decrease in IL-6, CASP1, NOS2, IL-1RAP, IL- 1B, IL-17, IL-12p40, M-CSF, CCL2/MCP-1, MIP-1a, MIP-2 and TNFRSF1A gene expression6. OxC- beta also has a multi-fold impact on signal transduction gene expression7)Canadian Journal of Chemistry, Burton GW et al, Beta-Carotene autoxidation: oxygen copolymerization, non-vitamin A products, and immunological activity, 2014. .

In order to accelerate the product launch, Avivagen has hired Bloom Burton & Co.’s strategic consultancy group in order to optimize the launch of the product into the US market, initially, including confirming the regulatory path, commercial strategy and timing. Avivagen will provide updates, as appropriate, on the launch into the US and into other markets as it gets closer to being commercially available.

About Avivagen
Avivagen is a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications. By unlocking an overlooked facet of β-carotene activity, a path has been opened to safely and economically support immune function, thereby promoting general health and performance in animals. Avivagen is a public corporation traded on the TSX Venture Exchange under the symbol VIV and is headquartered in Ottawa, Canada, based in partnership facilities of the National Research Council of Canada and Charlottetown, Prince Edward Island. For more information, visit www.avivagen.com. The contents of the website are expressly not incorporated by reference in this press release.

About Bloom Burton & Co.
Bloom Burton & Co. is a firm dedicated to accelerating returns in the healthcare sector for both investors and companies. Bloom Burton has an experienced team of medical, scientific, pharmaceutical, legal and capital markets professionals who perform a deep level of diligence, which combined with our creative and entrepreneurial approach, assists our clients in achieving the right monetization events. Bloom Burton and its affiliates provide capital raising, M&A advisory, equity research, business strategy and scientific consulting, advisory on direct investing and company creation and incubation services. Bloom Burton Securities Inc. is a member of the Investment Industry Regulatory Organization of Canada (IIROC) and is also a member of the Canadian Investor Protection Fund (CIPF). Please visit www.bloomburton.com to learn more.

About OxC-beta™ Technology and OxC-beta™ Livestock
Avivagen’s OxC-beta™ technology is derived from Avivagen discoveries about β-carotene and other carotenoids, compounds that give certain fruits and vegetables their bright colours. Through support of immune function the technology provides a non-antibiotic means of promoting health and growth. OxC-beta™ Livestock is a proprietary product shown to be an effective and economic alternative to the antibiotics commonly added to livestock feeds. The product is currently available for sale in the United States, Philippines, Taiwan, New Zealand, Thailand, Mexico, Australia and Malaysia.

Avivagen’s OxC-beta™ Livestock product is safe, effective and could fulfill the global mandate to remove all in-feed antibiotics as growth promoters. Numerous international livestock trials with poultry and swine using OxC-beta™ Livestock have proven that the product performs as well as, and, sometimes, in some aspects, better than in-feed antibiotics.

Forward Looking Statements
This news release includes certain forward-looking statements that are based upon the current expectations of management. Forward-looking statements involve risks and uncertainties associated with the business of Avivagen Inc. and the environment in which the business operates. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking, including those identified by the expressions “aim”, “anticipate”, “appear”, “believe”, “consider”, “could”, “estimate”, “expect”, “if”, “intend”, “goal”, “hope”, “likely”, “may”, “plan”, “possibly”, “potentially”, “pursue”, “seem”, “should”, “whether”, “will”, “would” and similar expressions. Statements set out in this news release relating to the possibility for OxC-beta™ Livestock to replace antibiotics in livestock feeds as well as fill a critical need for health support in certain livestock applications where antibiotics are precluded, Avivagen’s intention to launch a human supplement based on OxC-beta™ technology, Avivagen’s expectation as to effects of OxC-beta™ technology on humans based on the scientific research with respect to OxC-beta™ technology and its effects on non-humans, potential benefits and effects of Avivagen’s products to humans and the process and timing for regulatory approval and launch of an Avivagen supplement for human use are all forward-looking statements. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results or events to differ materially from current expectations. For instance, Avivagen’s products may not be widely accepted as a replacement for antibiotics in livestock feeds, there may not be a market for Avivagen’s products as a supplement for humans, the results of scientific research on the product’s effects on non-humans may not mean that the product will have similar effects on humans, the regulatory and product launch process may not occur in the timeline or manner expected by Avivagen or may not happen at all due to many factors, many of which are outside of Avivagen’s control. Readers are referred to the risk factors associated with the business of Avivagen set out in Avivagen’s most recent management’s discussion and analysis of financial condition available at www.SEDAR.com. Except as required by law, Avivagen assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward-looking statements.

Neither 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.

For more information:
Avivagen Inc.
Drew Basek
Director of Investor Relations
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6
Phone: 416-540-0733
E-mail: d.basek@avivagen.com

Kym Anthony
Chief Executive Officer
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6
Head Office Phone: 613-949-8164
Website: www.avivagen.com

 

References   [ + ]

1. PLoS ONE, Johnston JB et al, Biologically Active Polymers from Spontaneous Carotenoid Oxidation: A New Frontier in
Carotenoid Activity, 2014.
2. mBio, Totura AL et al, Toll-like Receptor 3 Signaling Via TRIF Contributes to a Protective Innate Immune Response To Severe Acute Respiratory Syndrome Coronavirus Infection, 2015.
3. Journal of General Virology, Cao L et al, Porcine Epidemic Diarrhea Virus Infection Induces NF-kB Activation Through the TLR2, TLR3 and TLR9 Pathways in Porcine Intestinal Epithelial Cells, 2015.
4. Journal of Virology, Khanolkar A et al, Toll-Like Receptor 4 Deficiency Increases Disease and Mortality after Mouse Hepatitis Virus Type I Infection of Susceptible C3H Mice, 2009.
5. Unpublished proof-of-principle results
6. American Journal of Veterinary Research, Duquette et al, Anti-inflammatory effects of retinoids and carotenoid derivatives on caspase-3–dependent apoptosis and efferocytosis of bovine neutrophils, 2014.
7. Canadian Journal of Chemistry, Burton GW et al, Beta-Carotene autoxidation: oxygen copolymerization, non-vitamin A products, and immunological activity, 2014.