FDA Grants Orphan Drug Designation to CK0804 Treg Therapy for Treatment of Myelofibrosis
“Receiving Orphan Drug Designation is an important milestone in the clinical development of CK0804 for myelofibrosis and underscores our commitment to advance CK0804 into phase 2 trials to address the unmet need for patients who have not responded to currently available therapies”, said Dr. Simrit Parmar, MD, Founder of Cellenkos. “The observed increase in IL-10 and decreases in TGFβ levels in CK0804 responders, together with reductions in pathogenic monocytes in plasma and bone marrow, support the disease modifying potential of CK0804 Tregs as a distinct and differentiated therapeutic class in myelofibrosis.”
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