CytoDyn Receives Orphan Drug Designation for PRO 140 for Prevention of Graft Versus Host Disease
VANCOUVER, Washington, Oct. 05, 2017 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB:CYDY), a biotechnology company focused on the development of new antibody therapies for combating human immunodeficiency virus (HIV) infection, announces that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to PRO 140 for the prevention of graft versus host disease (GvHD). Orphan drug designation is granted to development-stage drugs that have shown promise in addressing serious medical needs for patients living with rare conditions. This designation provides CytoDyn with various incentives and benefits including seven years of U.S. market exclusivity for PRO 140 in GvHD, subject to FDA approval for use in this indication.
“GvHD is a life-threatening complication following bone marrow transplantation in patients with leukemia who have compromised immune systems due to treatment with aggressive cancer therapies,” said CytoDyn Chief Science Officer Denis R. Burger, Ph.D. “We chose GvHD as the first non-HIV indication for PRO 140 as it targets and masks the CCR5 receptor on T cells. This receptor on T cells is an important mediator of inflammatory diseases including GvHD, especially in organ damage that is the most frequent cause of death in these patients. Prior clinical trials have shown PRO 140 to be safe and well tolerated, with negligible toxicities or side effects.”
