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Avivagen Announces Successful Completion of Formal Safety and Toxicology Evaluation of Fully Oxidized Beta-Carotene (OxBC)
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Rhea-AI Summary
Avivagen Inc. (TSXV:VIV, OTCQB:VIVXF) has completed crucial safety evaluations of its proprietary beta-carotene ingredient, OxBC, used in its OxC-beta™ product line for livestock and humans. The study confirms OxBC's safety and effectiveness, supporting its GRAS status in the U.S. and regulatory approvals in key markets like China and Brazil. Over 35 million livestock and 82,000 dogs have benefited from OxBC. The toxicology tests documented high maximum tolerated doses and no adverse effects, reinforcing OxBC's commercialization potential.
Positive
Completion of safety evaluations for OxBC supports its efficacy and safety for animal and human use.
OxBC has secured GRAS status in the U.S. and regulatory approval in multiple countries, enhancing market access.
Over 35 million livestock and 82,000 dogs have benefited from OxBC, showcasing strong product adoption.
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None.
OTTAWA, Ontario--(BUSINESS WIRE)--
Avivagen Inc. (TSXV:VIV, OTCQB:VIVXF) (“Avivagen”), a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that safely enhances feed intake and supports immune function, thereby supporting general health and performance, is pleased to announce that it has completed a series of important safety evaluations of fully oxidized beta-carotene (OxBC), the proprietary and critical active ingredient in the company’s highly-regarded OxC-beta™ product line. Results of the Avivagen-initiated toxicology study, conducted following standardized and internationally recognized protocols, provided further evidence of the safety and effectiveness of OxBC and the OxC-beta™product line for use in human and animal applications.
Based on previously conducted scientific testing, OxBC and Avivagen’s OxC-beta™ product line have achieved self-affirmed GRAS status in the United States and have already secured regulatory approval in a number of other important food and feed markets, including China, Brazil, Philippines, Mexico, Taiwan, New Zealand, Thailand, Vietnam, Australia, and Malaysia.
“Through extensive internal and third-party testing, and both regulatory evaluation and customer trial and adoption of our OxC-beta line around the globe, the safety of OxBC as an active ingredient supporting a wide range of beneficial uses for humans and animals has been shown again and again,” says Kym Anthony, Chief Executive Officer, Avivagen. “Already more than 35 million livestock animals have seen enhanced health and productivity thanks to the OxBC ingredient, and over 82,000 dogs and 3,300 humans have enjoyed the benefits of OxBC products. As expected, proactively participating in this toxicology assessment has provided further evidence of the safety and effectiveness of our OxC-beta™ line and presents a valuable indicator of the significant commercialization opportunities for our technology as we continue to expand approvals and adoptions in new markets worldwide.”
While there have been zero reports of product-related adverse events from OxBC or OxC-beta™to date, the present toxicology tests were initiated by Avivagen to further reinforce OxBC’s applicability as a very safe ingredient in a wide range of products and provide further formal evidence to support continued regulatory approval and adoption in both new jurisdictions and product applications. Toxicology testing consisted of three separate studies, all of which are conducted in animals, typically rats. The first test demonstrated that in rats the maximum tolerated single oral dose of OxBC and the LD50 were 5,000 and 30,079 mg/kg body weight, respectively. The second test, a 14-day, repeat-dose acute oral toxicity test demonstrated an initial No Observable Adverse Effect Level (NOAEL) of OxBC of 1,250 mg/kg body weight. In the third and final test, no mortality or morbidity was observed for administration by oral gavage of OxBC up to 1875 mg/kg body weight once daily in male and female Sprague Dawley rats for 90 consecutive days followed by a 28-day recovery period. There were no treatment-related adverse effects on body weight, feed consumption, hematology, coagulation, hormonal, and clinical chemistry parameters and organ weights. No gross pathological abnormalities nor adverse histopathological findings were observed. The NOAEL was determined to be 1875 mg/kg body weight. These findings strongly support the safety of OxBC, especially considering the NOAEL value exceeds by several thousand times the daily level of approximately 0.5 mg/kg body weight of OxBC used in supplementing livestock, canines, felines and humans.
About Avivagen Avivagen is a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that, by safely supporting immune function, promote general health and performance. It 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. For more information, visit www.avivagen.com. The contents of the website are expressly not incorporated by reference in this press release.
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, Mexico, Taiwan, New Zealand, Thailand, Brazil, 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 future growth and prospects for Avivagen and the possibility for OxC-beta™ Livestock to replace antibiotics in livestock feeds as growth promoters are 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 gain market acceptance or regulatory approval in new jurisdictions or for new applications and may not be widely accepted as a replacement for antibiotics as growth promoters in livestock feeds 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.
