November 30, 2004

Oragenics to Start Tooth Decay Tests

ALACHUA, Fla. -- Oragenics Inc. plans to start human safety studies of its replacement therapy early next year, using a genetically modified bacteria to battle decay caused by naturally occurring microbes already in the mouth.

The Food and Food and Drug Administration on Tuesday lifted a clinical hold on the tooth decay treatment.

In a press release Tuesday, the Alachua, Fla.-based biotechnology company said the FDA approved a Phase I trial after reviewing the study's clinical design.

"The idea is simply to use good bacteria to fight bad bacteria," Oragenics' chief scientific officer, Jeffrey D. Hillman, told The New York Times for a story in Tuesday's editions.

In May 2003, the FDA placed Replacement Therapy's Investigational New Drug application on clinical hold pending a review of the study's design. In March, an FDA advisory committee recommended that the trial should be carried out under the protocol proposed by Oragenics.

The first trial will involve 15 volunteers wearing dentures, to test the procedure's safety, the newspaper reported. Eventually, the trials will help determine if the bacteria is effective against fighting cavities.

Replacement Therapy treats dental caries, which is the demineralization of a tooth's surface caused by bacteria.

Separately, Oragenics said it completed the private placement of unregistered shares and warrants for total proceeds of $687,500. The company will use the funds to support clinical development projects and for general corporate purposes.

The company sold 250,000 shares for $2.75 a share. Each share receives one-half warrant for the purchase of more shares at $3.50 a share.

Shares of Oragenics rose 10.4 percent, or 33 cents, to $3.50 in early trading Tuesday on the American Stock Exchange.



U.S. Food and Drug Administration