Benzinga | Jan 21, 2022 05:18AM EST

Kura Oncology Receives FDA Authorization To Proceed With Phase 1b Study Of KO-539 In Acute Myeloid Leukemia

Kura Oncology, Inc. (NASDAQ:KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on the KOMET-001 Phase 1b study of KO-539 in patients with relapsed or refractory acute myeloid leukemia (AML). The partial clinical hold was lifted following agreement with the FDA on the Company's mitigation strategy for differentiation syndrome, a known adverse event related to differentiating agents in the treatment of AML.

"I am very proud of our team for working diligently with the FDA and site investigators to resolve the partial clinical hold in such a timely manner," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "Activities to resume patient screening are underway, and we look forward to expediting enrollment of patients in the Phase 1b study and determining the recommended Phase 2 dose for KO-539 in the coming months. Meanwhile, we continue to be encouraged by the safety, tolerability and clinical activity observed among currently enrolled patients and look forward to sharing a comprehensive update on the Phase 1 study at a future medical meeting."