A therapy trial for sickle cell pain
Carlotta Mohamed | 11/3/2013, 10:36 p.m. | Updated on 11/3/2013, 10:36 p.m.
Newark Beth Israel Medical Center is recruiting eligible patients for the sickle cell pain crisis phase 2 trial called SUSTAIN.
Selexys Pharmaceuticals, www.selexys.com, launched the SUSTAIN Phase 2 trial of its humanized monoclonal antibody SelG1 to reduce or prevent the occurrence of sickle cell-related pain crises, that will be conducted in approximately 70 locations in the U.S., Brazil and Jamaica including Newark Beth Israel Medical Center.
SelG1 prevents certain blood cells from binding to one another and to blood vessel walls. By stopping these cell to cell interactions, SelG1 may prevent small blood vessels from becoming plugged and reduce the occurrence and severity of pain crises and complications such as stroke, heart attack, and organ failure.
According to WedMd.com, symptoms of sickle cell disease include pain in the hands, feet, belly, back, or chest that can last for hours or days when sickle cells get stuck in blood vessels and block the blood flow, stopping oxygen from getting through. This is the cause of a pain crisis that occurs in patients with sickle cell.
Sickle cell disease data suggests that inhibiting the cell adhesion protein P-selectin prevents the painful blocking of circulation in small blood vessels called vasoocclusion and maintains normal blood flow.
The SUSTAIN trial will include approximately 175 patients who have had between two and 10 *good AP style pain crises in the year prior to entering the study. Patients will receive either high-dose SelG1, low-dose SelG1 or placebo. Patients currently on hydroxyurea therapy and patients not on this medication will be allowed to participate in the study. The primary goal to reduce the number of sickle cell-related pain crisis with SelG1 compared to placebo.