Enochian BioSciences, Inc. announced the completion of an Investigator Pre-Investigational New Drug (IND) process following receipt of written comments from the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT).Dr. Serhat Gumruk?u, co-founder and inventor of Enochian BioSciences, and Director of Seraph Research Institute (SRI), submitted an investigator-initiated Pre-IND. The request was based on the results of a 54-year old man living with HIV who had failed to suppress the virus with antiviral therapy (ART). The patient subsequently stopped taking ART and received an innovative treatment developed by SRI. Enochian BioSciences holds the exclusive license for the product. The patient?s HIV infection blood levels were controlled more effectively for 365 consecutive days, off ART using this new innovative SRI treatment compared to what had previously been achieved with ART. The proprietary therapy includes Natural Killer (NK) and Gamma Delta T-cells (GDT) collected from another person. During the entire period, no antiviral drugs were given. It is believed that the GDT cells, a small subset of immune cells that can be infected with HIV, could be a key factor in controlling the virus.