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- Kura Oncology (NASDAQ:KURA) announces that the FDA has placed the KOMET-001 Phase 1b study of KO-539 in patients with relapsed or refractory acute myeloid leukemia (AML) on a partial clinical hold.
- Shares down 35.2% premarket at $10.75.
- The partial clinical hold was initiated following the Company’s recent report of a Grade 5 serious adverse event (patient death) potentially associated with differentiation syndrome, a known adverse event related to differentiating agents in the treatment of AML.
- Patients currently enrolled in the Phase 1b study may continue to receive KO-539, although no additional patients may be enrolled until the partial clinical hold is resolved.
- “We share the FDA’s commitment to patient safety, and we appreciate our ongoing dialogue as we work diligently to address their questions,” said Troy Wilson, Ph.D., J.D., President and CEO of Kura Oncology.
- Until the partial clinical hold is resolved, Kura is suspending guidance on the completion of enrollment in the KOMET-001 Phase 1b study and determination of the recommended Phase 2 dose of KO-539.
- The company will host a conference call today at 8:30 a.m. ET.