Oragenics Announces Successful Completion of Pre-IND Meeting For OG253
TAMPA, Fla.-- Florida-based biopharmaceutical company Oragenics, Inc. (NYSE:MKT – OGEN) has announced today that it met representatives of the Food and Drug Administration (“FDA”) in a Pre-IND meeting concerning its lead lantibiotic compound, OG253 which is being evaluated for efficacy against C. difficile infections.
Lantibiotics are a class of antibiotics with a novel mechanism of action active against several multi-drug resistant organisms. Through its Exclusive Channel Collaboration (“ECC”), Oragenics has partnered with Intrexon Corporation Inc. (NYSE – XON), in the use of their proprietary bio-engineering capabilities to develop its lantibiotics compounds pipeline which could provide an important new tool in the fight against bacterial antibiotic resistance.
Dr. Frederick Telling, Oragenics’ Chairman, said, “Albert Fosmoe, Senior Vice President Operations/Product Development of Oragenics, and Suma Krishnan, Senior Vice President, Product Development & Head of Human Therapeutics Division of Intrexon, and their associated teams, have spearheaded the lantibiotic development program and I am pleased with the guidance they received and the clarification and concurrence of the work that we will need to complete in order to file an Investigational New Drug Application.” Dr. Telling also noted, “We look forward to strengthening our collaboration with Intrexon as we accelerate our efforts under our ECC for the development of lantibiotics, particularly in the further development of OG253 at Intrexon’s Budapest facility.”
About Oragenics, Inc.
We are focused on becoming the world leader in novel antibiotics against infectious disease. We also develop, market and sell proprietary probiotics specifically designed to enhance oral health for humans and pets and on developing effective treatments for oral mucositis. Oragenics, Inc. has established two exclusive worldwide channel collaborations with Intrexon Corporation Inc., a synthetic biology company. The collaborations allow Oragenics access to Intrexon's proprietary technologies toward the goal of accelerating the development of much needed new antibiotics that can work against resistant strains of bacteria and the development of biotherapeutics for oral mucositis and other diseases and conditions of the oral cavity, throat, and esophagus. Oragenics also develops, markets and sells proprietary OTC probiotics specifically designed to enhance oral health for humans and pets, under the brand names Evora and ProBiora both in the United States and through the use of distributors in locations outside of the United States.
For more information about Oragenics, www.oragenics.com.
Safe Harbor Statement: Under the Private Securities Litigation Reform Act of 1995: This release includes forward-looking statements that reflect management’s current views with respect to future events and performance. These forward-looking statements are based on management’s beliefs and assumptions and information currently available. The words “believe,” “expect,” “anticipate,” “intend,” “estimate,” “project” and similar expressions that do not relate solely to historical matters identify forward-looking statements. Investors should be cautious in relying on forward-looking statements because they are subject to a variety of risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed in any such forward-looking statements. These factors include, but are not limited to, any inability to obtain or delays in FDA approval for future clinical studies and testing, the future success of our studies and testing and any inability to also achieve favorable results in human studies, our ability to successfully develop and commercialize products, the financial resources available to us to continue research and development, and those other factors described in our filings with the U.S. Securities and Exchange Commission. Any responsibility to update forward-looking statements is expressly disclaimed.
Michael Sullivan, 813-286-7900
Chief Financial Officer
The Ruth Group
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Source: Oragenics, Inc.
Released November 18, 2015