June 14, 2022


Avivagen completes formal safety, toxicology evaluation of fully oxidised beta-carotene


Avivagen Inc. announced that it has completed a series of important safety evaluations of fully oxidised beta-carotene (OxBC), the proprietary and critical active ingredient in the company's highly-regarded OxC-betaTMproduct line.


Results of the Avivagen-initiated toxicology study, conducted following standardised and internationally recognised protocols, provided further evidence of the safety and effectiveness of the company's OxBC and the OxC-betaTM product line for use in human and animal applications.


Based on previously conducted scientific testing, OxBC and Avivagen's OxC-betaTMproduct 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," said Kym Anthony, chief executive officer of Avivagen. "Already more than 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-betaTMline and presents a valuable indicator of the significant commercialisation 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-betaTMto 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, Avivagen said.


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 5,000mg/kg and 30,079mg/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 1,250mg/kg body weight.


In the third and final test, no mortality or morbidity was observed for administration by oral gavage of OxBC up to 1875mg/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 1875mg/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 0.5mg/kg body weight of OxBC used in supplementing livestock, canines, felines and humans, said Avivagen.

- Avivagen

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