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Oragenics and Intrexon Report Positive In Vivo Antibiotic Efficacy Data in Critical Animal Study

Wednesday, August 19, 2015  
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Oragenics, Inc. and Intrexon Corporation, a leader in synthetic biology, announced today positive data on multiple compounds from Oragenics’ Mutacin 1140 (“MU1140”) lantibiotic platform in a critical animal model study, as well as the selection of a lead clinical candidate. The compounds were subjected to a standardized “proof of concept” animal model evaluating efficacy for reducing clinically relevantC. difficile infection(s) and increased survival relative to vancomycin positive control.

Lantibiotics are a class of antibiotics with a novel mechanism of action active against several multi-drug resistant infectious agents. Through its Exclusive Channel Collaboration (“ECC”), Oragenics has utilized Intrexon’s proprietary bio-engineering capabilities to develop its MU1140 analog pipeline which could provide an important new tool in the fight against global bacterial antibiotic resistance.

The tested compounds were selected based on important compound characteristics including, but not limited to: drug activity (based on minimum inhibitory concentration) equal or better than “standard of care” drugs against certain drug-resistant bacteria, safety, toxicity, stability, and manufacturability. The study specifically evaluated compound efficacy as measured by survivability, amounts of C. difficile colony forming units, and toxin levels. Overall several compounds demonstrated promising results, and Oragenics’ new lead clinical candidate achieved a 100% survival rate throughout the entire study in contrast to a 33% survival rate for the vancomycin (current standard of care) positive control. There was a 0% survival rate for the placebo control group.

Frederick Telling, Ph.D., Chairman of the Board of Oragenics said, “These test results represent a significant development and we are delighted to share this progress as we continue our efforts to develop lantibiotics, a new therapeutic class of antibiotics, with our collaborator Intrexon to combat the growing problem of resistance to existing therapeutics.” Dr. Telling added, “We remain on-track for our previously disclosed expectation of pre-IND meetings with the U.S. Food and Drug Administration in the fourth quarter. This in vivo efficacy data represents a significant step forward in the development path undertaken by Oragenics.”

Samuel Broder, M.D, Senior Vice President and Head of Intrexon’s Health Sector, stated, "We are very pleased that the suite of Intrexon technologies and proprietary industrial processes has facilitated the development of novel lantibiotics by our ECC partner, Oragenics. This is an important area of much needed new antibiotic development."

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