Selexys Pharmaceuticals has commenced a SUSTAIN Phase II trial to assess SelG1, an investigational anti-P-selectin humanised monoclonal antibody, in sickle cell patients with pain crises.
The multicentre, randomised, placebo-controlled, double-blind, twelve-month study will assess the safety and efficacy of SelG1 with or without hydroxyurea therapy in the patient group.
SelG1 prevents small blood vessels from becoming blocked and reduces the occurrence and severity of pain crises, in addition to downstream complications, by preventing certain blood cells from binding to one another and to the blood vessel walls.
University of North Carolina Hematology/Oncology division lead investigator and associate professor of medicine Dr Kenneth Ataga said, "Not only does it have the potential to improve the clinical outcomes in patients, its effects may be additive or synergistic with those of hydroxyurea, the only drug currently approved by the FDA for treatment of complications due to sickle cell disease."
Around 174 patients will be randomised with high dose SelG1, low dose SelG1 or placebo in the presence or absence of hydroxyurea therapy, the current standard of treatment.
SelG1's effectiveness in reducing the rate of sickle cell-related pain crises in each active dose level compared to placebo will be evaluated in the study, which will be conducted in approximately 60 centres throughout the US.
Selexys president and CEO Dr Scott Rollins said, "The SUSTAIN study focuses on the ability of our novel anti-P-selectin antibody to reduce or prevent the occurrence of pain crises and thereby improve the lives of patients with sickle cell, a disease that largely affects African-Americans in the US."
Image: Sickle-cell disease is a genetic blood disorder with over dominance, characterised by red blood cells that assume an abnormal, rigid, sickle shape. Photo courtesy of Dr Graham Beards.