Decay vaccine?? - Current
research
Obesity, Fitness & Wellness Week, April 17,
2004 p50
Committee votes in favor of human trial for dental caries prevention
therapy.
Full Text: COPYRIGHT 2004 NewsRX
2004 APR 17 - (NewsRx.com & NewsRx.net) -- Oragenics, Inc.,
(OGEN) announced that the Recombinant DNA Advisory Committee of
the U.S. National Institutes of Health 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 (IND) 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.
Oragenics, Inc. is an emerging biotechnology company focused on
the development and licensure of innovative products and technologies
for improving human health. The company's lead product is a novel
oral rinse for the prevention of tooth decay, which is anticipated
to enter clinical trials in 2004.
This article was prepared by Obesity, Fitness & Wellness Week
editors from staff and other reports. Copyright 2004, Obesity,
Fitness & Wellness Week via NewsRx.com & NewsRx.net.
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