The U.S. Food and Drug Administration (FDA) has cleared Global Cord Blood Corporation’s CO Investigational New Drug (IND) application to initiate a Phase 1b, clinical study of CK0804 as an add on therapy to ruxolitinib in patients with myelofibrosis who experience a suboptimal response to ruxolitinib.
The Phase 1b clinical trial is being launched in partnership with Incyte as part of their LIMBER initiative, will evaluate the safety of monthly doses of CK0804 as add on therapy in myelofibrosis patients who will continue treatment with ruxolitinib.
Tara Sadeghi, Chief Operating Officer, said, "We are thrilled to have received IND clearance for our CK0804 program in myelofibrosis, marking our fourth IND Clearance as a company and our second hematological malignancy program to reach clinical development.”
Ruxolitinib (Jakafi) is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. FDA for the treatment of polycythemia vera (PV) in adults. Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi (ruxolitinib) outside the United States.
Ekaterine Asatiani, M.D., Division Vice President and Head of Early Development at Incyte, commented, “We are pleased to be partnering with Cellenkos to initiate this new LIMBER study evaluating CK0804 and ruxolitinib as we continue to explore new treatment options for patients with myelofibrosis.”
Shares of Global Cord Blood are trading higher 11 percent at $3.29 in the after hour session.
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