The U.S. Food and Drug Administration (FDA) has granted pre-approval for Enochian BioSciences’ Investigational New Drug (IND) application for a potential functional treatment or cure for HIV (human immunodeficiency disorder). The submission is based off of an innovative cellular therapy that was administered to a 54 year old man diagnosed with HIV, which initially had failed to suppress the virus with antiviral therapy. Over a 255 day treatment period, the patient received Natural Killer (NK) and Gamma Delta T-cells (GDT), a small immune cell collection that can be infected with HIV, taken from a different individual while receiving zero antiviral medications.
“As an HIV researcher, clinician and past leader of large, global HIV programs, I am very excited by the FDA’s decision to provide responses to the Pre-IND submission. Because the promising early results are only in one person, it is important to study the approach in a larger population. In addition, because many people achieve suppression with antiviral treatment, it is key to extend the evaluation to that specific group. Pre-IND is an important step to exploring the possibility of testing this novel NK-GDT treatment,” stated Executive Vice Chairperson of the Board of Enochian BioSciences, Dr. Mark Dybul.
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