Selexys Pharmaceuticals, a privately held biopharmaceutical company based in Oklahoma City, Okla., has completed a phase I clinical study of its lead compound SelG1, an antibody specific for the pro-inflammatory cell adhesion molecule P-selectin.
The placebo-controlled, double-blind, ascending single dose and multiple dose study of SelG1 enrolled 27 healthy subjects. The study evaluated the safety and pharmacology of SelG1 to support its advancement into a phase II clinical trial in patients with sickle cell disease.
SelG1 appeared to be 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 demonstrated a serum half-life of approximately two weeks and complete blockade of P-selectin activity in all patients for at least one month following a single intravenous dose.
"This phase I study represents a major step in understanding the potential of SelG1 to address the unmet medical need in sickle cell disease and other indications," said Dr. Scott Rollins, president and CEO of Selexys.
In 2008, Selexys received orphan-drug designation for SelG1 from the FDAn Office of Orphan Products Development for the treatment of vasoocclusive crisis, a severe and painful complication of sickle cell disease.