Bio-Technology General Corp. (BTG) announced that it hasinitiated its clinical study on the intratracheal delivery ofsuperoxide dismutase (SOD) in premature neonates.
The New York company received the go-ahead from FDA onMonday to assess the therapeutic utility of recombinant humanSOD in preventing bronchopulmonary dysplasia (BPD) inpremature infants.
Excess oxygen free-radicals in the neonate lung have beenimplicated as a cause of acute injury leading to permanenttissue damage, which results in BPD. Up to 60 percent of the50,000 premature neonates born yearly in the U.S. contractrespiratory distress syndrome. Of those, 60 percent developBPD and require lengthy hospitalization.
BTG's recombinant SOD has orphan drug status for preventingBPD in neonates. As well, BTG (NASDAQ:BTGC) recently wasissued U.S. Patent No. 5,116,616 for using intratrachealadministration of SOD to protect humans from lung injury dueto hyperoxia and hyperventilation.
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