The patients in the 8 week dose escalation study were treated at dose levels between 0.3 and 12 mg/kg and have also received 5 injections of SM101 during the treatment cycle.
The trial demonstrated that patients, who have received single cycle of SM101 have shown sustained increase in platelet count while no safety concerns have been identified in patients who have received dose levels up to 12 mg/kg SM101.
ITP treatment expert David Kuter said SM101has a new mechanism of action designed to selectively modulate the immune response.
”Early clinical data presented at ASH suggest that it has the potential to provide a prolonged increase in platelet counts in patients with ITP," Kuter added.
SuppreMol is carrying on dose-escalation trial in ITP in Europe and is also planning to initiate a randomised phase II clinical trial in ITP in the US and Europe in 2013.
SM101 is a recombinant, soluble, non-glycosylated version of the Fcgamma-receptor IIB that binds to autoantibody/autoantigen complexes and blocks the activation of Fc receptors on the surface of immune cells.