updated 12/1/2004 2:47:22 PM ET 2004-12-01T19:47:22

A biotech company has won approval to conduct human trials of a dental treatment that uses genetically modified bacteria to prevent cavities for a lifetime, after resolving regulators’ safety concerns.

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Oragenics Inc. said Tuesday that trials of the product, known as Replacement Therapy, would get underway early next year. The company’s shares surged 20 percent on the news.

The announcement comes roughly a year-and-a-half after the Food and Drug Administration put the Alachua, Fla.-based company’s trials on hold pending modifications to better protect test subjects. The Oragenics’ therapy replaces the bacteria that convert sugar to lactic acid, which causes cavities, with genetically modified bacteria that do not produce lactic acid. The company says the one-time application, which is swabbed directly onto the teeth, takes about a year to fully take effect.

The FDA, which declined to comment Tuesday, wanted to make sure Oragenics could quickly remove the genetically modified bacteria from a test subject’s teeth should something go wrong, said Oragenics’ president and chief executive Chuck Soponis. The agency was also concerned about the possibility the bacteria could be spread by kissing or other close contact.

“You have to appreciate that replacement therapy has never been done before; this is FDA’s first impression of it,” Soponis said.

Safety changes
In the safety study, Oragenics will use a strain of the genetically modified bacteria that requires a daily feeding of an amino acid that does not occur in the body in order to stay alive.

Another modification to the original trial plan is that participants in the clinical trial will be denture wearers, Soponis said. That way, if the bacteria need to be quickly eliminated for safety reasons, the dentures can be taken out of the mouth and soaked in bleach.

The Phase I safety trial will enroll 15 people along with their partners or spouses to test the communicability of the genetically modified bacteria.

“The FDA wanted people enrolled with their spouses or partners to see if the bacteria was horizontally transmissible,” Soponis said. The company does not believe the bacteria can be spread from person to person.

If all goes well, the company will proceed onto further trials with a version of the bacteria that does not require the amino acid to survive, thereby providing the lifelong benefit. Eventually, people who have their own teeth will be enrolled to test the treatment’s efficacy.

Soponis said he hopes to see Replacement Therapy on the market in the next four to five years.

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