Cellenkos announced that 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.
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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.
"The timely clearance of this IND and commencement of the Phase I trial will unlock the tremendous potential of cellular therapy application for neuro-inflammatory disorders. This is yet another significant milestone for Cellenkos, and marks an important step forward in finding effective treatments for autoimmune diseases", said Founder and Chief Medical Officer, Simrit Parmar, MD. "For a rare and debilitating disease with no known cure, this is an exciting opportunity to bring a novel cellular therapy, CK0801 that works to replace and replenish the defective regulatory T cells and protects the neurological system from the constant attack as a result of uncontrolled inflammatory signals. Such an interruption of the neural insult loop can allow for reinstating the immune balance and support neuron regeneration leading to clinical improvement".