Avivagen Reports Positive Proof Of Concept In Preventing C. Difficile Infection
OTTAWA, April 10, 2017 (GLOBE NEWSWIRE) -- Avivagen Inc. (TSXV:VIV) (OTC Pink:CHEXF) (Avivagen or the Corporation), a company with a proven and commercially-ready, patent-protected product intended to replace the antibiotics added to livestock feeds as growth promoters, announces positive results from a proof-of-concept study that could extend Avivagen’s OxC-beta™ technology into human health applications.
The proof-of-concept study evaluated Avivagen’s OxC-beta™ technology as a preventative therapeutic against C. difficile infection (CDI). As strains of C. difficile change, antibiotics are becoming less effective or even completely ineffective in clearing CDI. It is estimated that CDI adds an annual economic burden of US$1.5 billion to the United States healthcare system. 1
The proof-of-concept study evaluated three doses of the OxC-beta™ technology for the ability to improve survival rate, increase median time until death, and improve clinical indicators of health using a standard mouse model of human C. difficile infection. The research was conducted by the National Research Council of Canada (NRC), the Government of Canada’s premier research organization supporting industrial innovation, the advancement of knowledge, technology development, and fulfilling government mandates.
The results of the study demonstrate that the highest dose of the OxC-beta™ technology tested increased survivability and clinical scores in mice compared to the un-supplemented mouse control group. Treatment with the OxC-beta™ technology increased median time until death to greater than seven days in the mouse group treated with OxC-beta compared to only three days in the un-supplemented mouse control group.
Dr. James (Jamie) Nickerson, Avivagen’s Director of Product Validation, commented on the results, “We are very pleased with the outcome of this study, which establish proof of concept for the application of our OxC-beta™ technology in preventing C. difficile infection. We are now planning to move forward, in collaboration with the NRC, to conduct additional pre-clinical studies that will test higher doses of our technology to determine its effective dose range — with the ultimate goal of evaluating the technology in humans.”
About Avivagen
Avivagen Inc. is a public company traded on the TSXV 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.
About OxC-beta™ Technology and OxC-beta™ Livestock
Avivagen’s OxC-beta™ technology is derived from Avivagen discoveries about carotenoids, compounds that give certain fruits and vegetables their bright colors and is a non-antibiotic means of maintaining optimal health and growth. OxC-beta™ Livestock is a proprietary product shown to be effective and economic in replacing the antibiotics commonly added to livestock feeds. OxC-beta™ Livestock is currently registered and available for sale in the Philippines, Taiwan and Thailand.
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.
References
- Leffler DA et al. N Engl J Med 2015; 372: 1539-1548
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”, “goal”, ”helps”, “hope”, “if’, “intend”, “likely”, “may”, “plan”, “possibly”, “potentially”, “pursue”, “seem”, “should”, “whether”, “will”, “would” and similar expressions.
Statements or assumptions including whether antibiotics will continue to be less effective In clearing CDI, whether estimates of the economic burden of CDI in the United States are accurate, whether the CDC estimate of the annual number of C. difficile infections and deaths is accurate, , the proof-of-concept study or the relevance of results, whether Avivagen’s technology can be extended into human health applications, whether the proof-of-concept study will result in patentable intellectual property, , Avivagen’s intentions for future studies, statements about the NRC or CDC, the uses of the technologies described in this news release, including their importance to animal or human health, their novelty, safety, efficacy or affordability, or other statements or opinions of management, 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. Such risks and uncertainties include, but are not limited to: whether: Avivagen will be able to maintain existing proofs-of-concept in animals or establish new ones in humans or other animal species; Avivagen or others can replicate the results of the small mouse proof-of-concept study, whether in mice, other species or humans, if at all; further studies will provide similar results to that observed in the proof-of-concept study, if at all; Avivagen can complete trials with results sufficient to support patent filings, regulatory approvals or commercial sales; Avivagen can use the results of trials to support applications for regulatory approval in humans; Avivagen can obtain patent protection for a human application of OxC-beta, if at all; Avivagen can successfully prosecute and maintain its existing patents and trademarks, Avivagen can achieve new patent and trademark allowances and enforce the claims; Avivagen can maintain and obtain relevant regulatory and government approvals to market and sell OxC-beta; Avivagen can establish and maintain commercial relationships that result in sales; Avivagen can maintain its working capital position and sufficient funding to achieve its corporate goals; and can maintain its ability to continue as a going concern. Accordingly, readers should not place undue reliance on forward-looking statements. 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.
Copyright © 2017 Avivagen Inc. OxC-beta™ is a trademark of Avivagen Inc.
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, Interim Chief Executive Officer 100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Head Office Phone: 613-949-8164 Website: www.avivagen.com