CytoDyn starts Phase II of PRO 140 to treat GvHD

CytoDyn Inc. (OTCQB:CYDY) began a Phase II trial of PRO 140 to prevent acute graft-versus-host disease (GvHD) in patients with acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) undergoing allogeneic stem cell transplant (ASCT). The double-blind, placebo-controlled, U.S. trial is evaluating 350 mg subcutaneous PRO 140 given 2-3 days prior to stem cell infusion, on the day of infusion, weekly for 30 days and then every 2 weeks until week 14.

The primary endpoint is the incidence of grade II, III or IV acute GvHD by day 100. Secondary endpoints include incidence of grade III and IV GvHD by day 100, incidence of organ-specific acute GvHD, donor engraftment, neutrophil count recovery, platelet count recovery, change in Eastern Cooperative Oncology Group (ECOG) performance score and GvHD-free survival...