Cytodyn Inc., of Vancouver, Washington, said it submitted an application for FDA orphan status for PRO 140 (humanized monoclonal antibody to CCR5) for the pretreatment of HIV-1 infection in treatment-naïve adults who are awaiting drug resistance assay results to construct a highly active antiretroviral therapy regimen, a process that typically takes about two weeks. Cytodyn recently submitted a protocol for a phase IIb trial in treatment-naïve adults.