Israeli firm Bio-Technology General has started a multicenter Phase IIIstudy of its recombinant superoxide dismutase (SOD) orphan drug product, OxSODrol, in premature newborns in the USA. OxSODrol will be administered intratracheally and its effects on the prevention of bronchopulmonary dysplasia (BPD) will be assessed.
There are about 50,000 premature infants born in the USA with respiratory syncytial virus infection, and 60% of these go on to develop BPD. Excess oxygen free radicals in the neonate lung have been implicated as a cause of the acute injury which can lead to permanent tissue damage. SOD is one of the enzymes which can degrade these free radicals, along with others such as peroxidase and catalase.
The study will look at the effect of prophylactic administration of OxSODrol on the development of BPD.
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