By Lisa Seachrist
WASHINGTON — When a Phase III trial fails to reach its endpoint, it's usually a disaster for the company.
So when Bio-Technology General Corp., saw its Phase III study of OxSODrol, superoxide dismutase administered intratracheally, fail to prevent bronchopulmonary dysplasia (BPD) and death in premature infants, it was reasonable to assume the drug had received a fatal blow.
However, the company found some good news in the middle of the failed trial. The Phase III study's independent data and safety monitoring committee and the FDA encouraged Bio-Technology General to alter the endpoints to examine asthma complications and neurodevelopmental deficits in the patients. The shift was based on newly analyzed data from a Phase I study showing infants experienced fewer asthmatic complications and neurodevelopmental deficits 12 months after a 28-day treatment regimen.
The new trial, which won't require additional treatment of the 297 enrolled infants, will be a Phase II study and will be completed early next year.
"We didn't hit our endpoint in BPD," said Leah Berkovits, director of corporate communications for the Iselin, N.J.-based company. "But we see this as a positive development. A year from now we will know the Phase II results."
Berkovits noted the company was being cautious in projecting results of the new study because Phase I data are far from conclusive. Nevertheless, the new trial does breathe new life into the product.
Bio-Technology General's stock (NASDAQ:BTGC) closed at $7.094 per share, down $0.03. *