Dec 19 2011
Selexys Pharmaceuticals announced today that it 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, Selexys president and CEO. "This trial completion marks a key milestone for Selexys as we prepare to initiate a large Phase II efficacy study of this novel compound in patients with sickle cell disease."
In 2008, Selexys received orphan-drug designation for SelG1 from the Food and Drug Administration Office of Orphan Products Development for the treatment of vasoocclusive crisis, a severe and painful complication of sickle cell disease. Orphan drug designation in the United States is awarded to therapeutics with the potential for safe and effective treatment, diagnosis or prevention of rare diseases and disorders that affect fewer than 200,000 people.
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