Symbiotic control of tooth decay replaces the common mouth bacterium Streptococcus mutans, with a genetically altered version that is capable of out competing the native counterpart bacteria. The modified symbionts are unable to convert glucose to lactic acid, thereby providing protection against a common form of tooth decay.
We direct all inquires on this subject to the work of Jeffrey Hillman.
Contact and Specific Information
Jeffrey D. Hillman
Oral Biology, Professor
Ph.D., Harvard University, Microbiology and Molecular Genetics, 1976
D.M.D., Harvard School of Dental Medicine, Dentistry, 1973
University of Chicago, Biology
Molecular genetic approach to the following research topics:
Effector strain construction for the prevention of bacterial infections using replacement therapy.
Purification and characterization of novel lantibiotics from Streptococci. Construction and testing of several novel in vivo expression systems to identify new bacterial virulence factors.
The open letter from President of Oragenics, Robert T. Zahradnik
October 31, 2007
Dear Friends of ONI,
I am delighted to report that the U.S. Food & Drug Administration (FDA) has given us the go-ahead to conduct a second human safety trial with our SMaRT Replacement Therapy™ for preventing tooth decay. Our product development program has experienced regulatory delays as a result of the FDA’s rigorous review of the protocol for this novel technology. We feel, however, that we now have a well designed and achievable study protocol to evaluate the safety of our innovative approach for preventing tooth decay in humans.
The global market opportunity for the SMaRT™ technology to prevent dental cavities is enormous, as five billion people worldwide are currently affected by dental decay Instead of experiencing a continued decrease in the number of untreated dental cavities, some developed nations such as the United States are beginning to see an increase in the number of people who have untreated dental cavities. The need for better and more cost-effective dental preventive measures was dramatically highlighted in an October 11, 2007 New York Times article, which stated that the percentage of Americans with untreated cavities began rising this decade, reversing a half-century trend of improvement in dental health. Tragically, a child in Mississippi and another in Maryland died this year from infections caused by decayed teeth. This is certainly not a common occurrence, but the NY Times article correctly identified what is a widespread problem in America involving the limited access of poor children to routine dental services. This is a significant public health problem in many other parts of the world as well. In 2000, the then U.S. Surgeon General, David Satcher, referred to dental and oral diseases as a “silent epidemic” and called for action to promote access to oral health care for all Americans, especially for the disadvantaged and minority children. Our SMaRT™ technology may be able to play a significant role in addressing this global healthcare need when our product completes the regulatory review process and is approved for marketing to the dental profession.
As always, if you have any questions regarding the FDA clinical trial go-ahead announcement or any other company matters, please contact me and I will be happy to answer your questions.
Robert T. Zahradnik, PhD
President & CEO
Oragenics Receives FDA Go-Ahead for SMaRT Replacement Therapy™ Trial
FOR IMMEDIATE RELEASE
ALACHUA, FL (October 31, 2007) – Oragenics, Inc. (AMEX:ONI) announced today that it has received notification from the U.S. Food and Drug Administration (FDA) that the most recent submission of its Investigational New Drug Application (IND) for SMaRT Replacement Therapy™ had satisfactorily addressed all outstanding clinical hold issues, and that the company may now proceed with its second Phase 1 clinical trial. The study protocol is designed as an open label, single dose study for the evaluation of the safety and tolerability of the SMaRT™ replacement strain, A2JM, in healthy, adult male subjects, and includes an institutionalized phase during the clinical trial.
SMaRT Replacement Therapy™ is a patented technology discovered by Oragenics’ Chief Scientific Officer, Dr. Jeffrey Hillman, and represents a novel approach to preventing tooth decay. The SMaRT™ technology is a modified bacterial strain that is virtually identical to the decay-causing bacteria normally found on human teeth, but it does not cause tooth decay and it is designed to replace these resident decay-causing bacteria. The company initiated its first Phase 1 trial with SMaRT Replacement Therapy™ in the U.S. in April, 2005. The new trial is scheduled to last approximately six weeks, with a long-term follow-up evaluation at six months.
Dr. Robert Zahradnik, Oragenics’ President and CEO, stated, “We have worked diligently with the FDA in the design of this trial, and we are pleased that all clinical hold issues have been resolved and that we will now be able to move forward with the second safety trial for this innovative technology.” Oragenics expects to pursue Institutional Review Board (IRB) approval and it anticipates initiating subject recruitment in early 2008. Current plans are to conduct this trial in the U.S. at a single, qualified clinical trial site.
On a related issue, the Company announced that the Japanese Patent Office issued a patent for the application “Replacement Therapy for Dental Caries”. This patent should further strengthen the intellectual property protection surrounding Oragenics’ SMaRT Replacement Therapy™ technology.
Oragenics, Inc. is a biopharmaceutical company with a pipeline of proprietary technologies. The Company has a number of products in discovery, preclinical and clinical development, with a concentration in two main therapeutic areas, infectious disease and oncology. Our core pipeline includes products for use in the treatment of dental and periodontal infectious diseases, systemic bacterial infections, and for use in weight management. In the discovery stage are three platform technologies for identifying biomarkers of infection, cancer and autoimmune diseases and for the solid state synthesis of bioactive peptides including small molecule antibiotics.
Safe Harbor Statement: Under the Private Securities Litigation Reform Act of 1995: This release includes forward-looking statements that reflect Oragenics’ current views with respect to future events and financial 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 those set forth in our most recently filed annual report on Form 10-KSB and quarterly report on Form 10-QSB, and other factors detailed from time to time in filings with the Securities and Exchange Commission. We expressly disclaim any responsibility to update forward-looking statements.
Robert T. Zahradnik
13700 Progress Blvd.
Alachua, FL 32615