CytoDyn Receives FDA Clearance for Its First Non-HIV Indication for PRO 140

VANCOUVER, Wash., Dec. 14, 2015, CYDY, (GLOBE NEWSWIRE) CytoDyn Inc. (OTCQB:CYDY), a biotechnology company focused on the development of new therapies for combating human immunodeficiency virus (HIV) infection, today announced that it has been cleared by the FDA to conduct a Phase 2 trial for Graft versus Host Disease (GvHD), which is a life-threatening complication for patients undergoing stem cell transplants. CytoDyn currently is conducting a Phase 3 pivotal trial with its lead product candidate, PRO 140, for the treatment of HIV. The approved GvHD clinical trial is a Phase 2, randomized, double-blind, placebo-controlled, multi-center study. It evaluates the safety and efficacy of PRO 140 for prophylaxis of acute GvHD in patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) undergoing allogeneic stem-cell transplantation. The trial is a 100-day study with 60 patients. Positive results from this study would allow the Company to file for a breakthrough designa


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