Cero Therapeutics receives FDA Fast Track designation for CER-1236

CERo Therapeutics (CERO) announces that the U.S. Food and Drug Administration has granted Fast Track Designation to the Company’s lead investigational compound, CER-1236 for Acute Myeloid Leukemia. This designation is in addition to the existing Orphan Drug Designation for the compound. The first-in-human, multi-center, open label, Phase 1/1b study, currently underway, is designed to evaluate the safety and preliminary efficacy of CER-1236 in patients with acute myeloid leukemia that is either relapsed/refractory, or in remission with measurable residual disease, or newly diagnosed patients with TP53 mutated MDS/AML or AML. The two-part study has begun with dose escalation to determine the highest tolerated dose and recommended dose for Phase 2, followed by an expansion phase to evaluate safety and efficacy. Primary outcome measures include incidence of adverse events and serious adverse events, incidence of dose limited toxicities and estimation of overall response rate, complete response, composite complete response, and measurable residual disease. Secondary outcome measures include pharmacokinetics