Oragenics, Inc. (OTC:OGEN)(TSX VENTURE:ORA.U) announced today that the Recombinant DNA Advisory Committee (RAC) of the National Institutes of Health (NIH) has voted unanimously that the first human clinical study of Oragenics' Replacement Therapy for the treatment of dental caries should be carried out under the protocol proposed by the company.
The RAC serves as an advisory committee to the U.S. Food and Drug Administration (FDA) on new human clinical studies employing
genetically engineered organisms or gene therapy. Oragenics
voluntarily submitted its protocol for Replacement Therapy to the RAC at the suggestion of the FDA, which had placed the company's
Investigational New Drug application on clinical hold in May 2003
pending further review. The FDA is not bound by the recommendations of
the RAC.
"We are very pleased with the RAC's determination that our study design adequately addresses the safety questions posed by the first human clinical trial of our novel Replacement Therapy," said Chuck Soponis, Oragenics' president and chief executive officer. "We will be meeting with the FDA in the coming weeks to further discuss a lifting of the clinical hold on our IND, and we hope to initiate human testing later in the year."
Replacement Therapy is a single, painless topical treatment that
has the potential to offer life-long protection from most tooth decay. Tooth decay is caused by lactic acid produced by a bacterium in the mouth called Streptococcus mutans. Oragenics' Replacement Therapy employs a patented, genetically modified strain of S. mutans that does not produce this decay-producing acid. When applied to a person's teeth by a dentist, this engineered bacterium displaces the resident acid-producing bacterium, providing potentially life-long protection against most dental decay. Replacement therapy is the result of 25 years of research by Oragenics' founder and chief scientific officer,
Jeffrey Hillman, DMD, PhD, a noted molecular geneticist and expert on oral microbiology. Oragenics plans to initiate Phase I trials of this treatment during 2004 and to partner with a major healthcare products or pharmaceutical firm prior to initiating later stages of clinical testing.
