The placebo-controlled, double-blind, ascending single dose and multiple dose study of SelG1 enrolled 27 healthy subjects. The trial assessed the safety and pharmacology of SelG1 to support its advancement into a Phase II study in patients with sickle cell disease.
SelG1 was safe and well tolerated, with no serious adverse events reported in any subjects. There was no observed immune response to SelG1 during the study. Analysis of SelG1 pharmacokinetic and pharmacodynamic data showed a serum half-life of about two weeks and complete blockade of P-selectin activity in all patients for at least one month following a single intravenous dose.
In 2008, SelG1 was granted Orphan Drug status by the US Food and Drug Administration (FDA) for the treatment of vasoocclusive crisis, a severe and painful complication of sickle cell disease.
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