By Lisa Seachrist

Washington Editor

Bio-Technology General Corp. (BTGC) has initiated a Phase III multicenter clinical trial of its recombinant superoxide dismutase, OxSODrol, in premature infants. The company is testing the drug's ability to prevent lung damage common among preemies.

"OxSODrol could be an important therapy for these babies," said Leah Berkovits, director of corporate communications for the Iselin, N.J., company. "And, currently there are no drugs to prevent the damage to their lungs."

As such, the drug has been given orphan drug status by the FDA.

Super oxide dismutase (SOD) is an enzyme produced throughout the human body to scavenge and neutralize tissue-damaging oxygen free radicals. During inflammation, immune cells release large amounts of these reactive oxygen species to kill bacteria and virus-infected cells. SOD serves as a brake to the inflammation, mopping up the free radicals before they cause too much tissue damage.

The 50,000 premature infants born each year in the U.S. have an extremely high risk for oxygen free radical damage in their lungs. Because these infants are put directly into the high oxygen environment of a neonatal incubator, their lungs are exposed to much higher concentrations of oxygen than found in normal air. With more oxygen available, simply breathing produces more reactive oxygen species.

In addition, these infants don't yet produce enough SOD to handle normal amounts of oxygen free radicals in their lungs. The high levels of reactive oxygen species injure the fragile tissue in the lungs leaving them fibrotic and non-functioning. As a result, nearly 60 percent of all premature infants will develop bronchopulmonary dysplasia that can lead to life-long lung problems.

Bio-Technology General developed OxSODrol as way of providing the SOD that preemies lack and preventing lung damage. After Phase I studies and discussions with the FDA, the company decided to launch a Phase III trial at 10 clinical centers in the U.S.

The company is testing OxSODrol given every other day for 28 days through the infants' trachea tubes vs. a placebo. The trial is a randomized, double-blind, placebo controlled study that will take between 12 and 18 months to complete.

"We are working with the very low birth weight babies in this trial * the three-pounders," Berkovits said. "All of these babies have trachea tubes as part of standard care, so we aren't adding unnecessary procedures."

Although SOD plays an important role in all forms of inflammation, the company doesn't currently have plans to take the drug to further studies. "SOD could potentially be useful in a wide variety of inflammatory situations. But, we simply don't know yet," Berkovits said. "If we show efficacy with one indication, there will be a lot of research activity in SOD."

Gary Davis, senior analyst at Jessop Lamont Securities Corp. in New York, agreed with Berkovits' assessment and noted that all previous attempts to find an indication for SOD have failed. "But, that's not so unusual in biotech," said Davis. "Interferon, for one, failed to show efficacy at first and is now finding indications."

Davis also told BioWorld Today that OxSODrol could be a significant product for the company because it would need to be given prophylactically to all premature infants. Davis roughly estimated that the course of treatment would cost $10,000.

BTGC's stock (NASDAQ:BTGC) closed Thursday at $14.062, down $0.688.*