A Phase II trial of GMI-1070 as a treatment for vaso-occlusive crisis of sickle cell disease has begun, after the US Food and Drug Administration granted the drug a fast-track designation.
Vaso-occlusive crisis is a life-threatening condition where sickle cells get stuck within a blood vessel, impeding blood flow.
The study is designed to measure the effects of GMI-1070, a pan-selectin inhibitor, in blocking the inflammatory process underlying cell adhesion, thereby reducing the duration and intensity of vaso-occlusive episodes.
It will also measure the efficacy, safety and pharmacokinetics of GMI-1070 in hospitalised sickle cell disease patients experiencing vaso-occlusive crisis.
The drug is developed by GlycoMimetics, a clinical-stage biotechnology company manufacturing.