Cellenkos, Inc. announces FDA clearance of CK0801 Investigational NDA for Treatment-Resistant Guillain-Barré Syndrome
Cellenkos, Inc., a clinical-stage biotechnology company, announced that the United States Food and Drug Administration has cleared its Investigational New Drug (IND) application to proceed with a phase I clinical trial of CK0801, allogeneic cord blood-derived regulatory T cells, in patients with treatment-resistant Guillain-Barré Syndrome (GBS). Cellenkos submitted its IND application on September 11, 2018 and received approval on October 11, 2018. The Phase I clinical trial of CK0801 will be led by Kazim Sheikh, MD, Professor and Director of the Neuromuscular Program at the University of Texas Health Sciences Center at Houston (UTHealth), Houston, Texas.