Leukine GM-CSF data

IMNX (Seattle) reported results from a cohort of a Phase III study of Leukine for the prevention of serious infections in 60 premature, high-risk infants weighing 500 to 1,000 grams. The FDA asked the company to run the cohort study to verify safety of the drug.

Serious infections, including meningitis and sepsis, occurred in 5 of 29 of treated infants (17 percent) versus 12 of 31 (39 percent) of infants on placebo. Infants were treated for 28 days; dose and schedule haven't been disclosed. ...