Cellenkos™, Inc. Announces FDA Clearance of Investigational New Drug Application for CK0801 for Bone Marrow Failure Syndromes
Cellenkos™, Inc., a clinical-stage biotechnology company, today announced that the United States Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application which allows for Cellenkos™ to proceed with a phase I clinical trial of CK0801, 3rd party cord blood derived regulatory T cells, in patients with bone marrow failure syndrome including aplastic anemia, myelodysplastic syndrome and myelofibrosis. Cellenkos™ submitted its IND application on May 11, 2018. The Phase I clinical trial of CK0801 will commence in the third quarter of 2018 at The University of Texas MD Anderson Cancer Center, Houston, Texas.
"The clearance of this IND is a significant milestone for Cellenkos™ and for its' platform technology, CK0801, as part of the overall clinical development plan of demonstrating adoptive cellular therapy with CK0801 to treat autoimmune diseases and inflammatory disorders", said Founder and Chief Medical Officer, Simrit Parmar, MD. "We are excited to launch the development of CK0801 as a novel cellular therapy approach to treat bone marrow dysfunction arising due to irregularities in the patient's immune system. CK0801 works to replace and replenish the defective regulatory T cells and blocks the uncontrolled inflammatory signal generated by the cytotoxic T cells against patients' own tissues. Such an approach may lead to calming of the bone marrow inflammatory microenvironment as a result of the infused CK0801 which may then lead to the reversal of the hematopoietic arrest that will potentially translate into clinical improvement."
Tara Sadeghi, Senior Clinical Director, added, "The US FDA's clearance of this IND validates our commitment towards creating an 'off-the-shelf' cord blood derived regulatory T cell therapeutic platform for treating autoimmune diseases. We are confident and eager that this Phase I study will confirm the safety of CK0801. We remain grateful to all our colleagues and partners in academia, whose constant support and guidance allows us to take this step forward."
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SOURCE Cellenkos, Inc.