Oryzon announces authorization in Spain of VIVALDI, a collaborative clinical study with CETLAM to evaluate iadademstat in combination with standard-of-care therapy in high-risk newly-diagnosed AML subpopulations
CETLAM sponsors this Phase Ib pilot study in European patients with newly diagnosed AML in subpopulations with poor responses to standard-of-care treatment. Thirteen hospitals will participate.
Oryzon Genomics, S.A, a clinical-stage biopharmaceutical company and global leader in epigenetics, today announced that VIVALDI, a Phase Ib pilot study sponsored by CETLAM — Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplásicas, has been authorized in Spain. The study will evaluate iadademstat in combination with azacitidine and venetoclax in patients with newly diagnosed acute myeloid leukemia (ND-AML) belonging to subgroups associated with suboptimal responses to current standard-of-care treatment.
CETLAM is a Spanish cooperative clinical research group that brings together specialists from leading hospitals in the research and treatment of acute myeloid leukemia and myelodysplastic syndromes. The group has more than three decades of experience in developing treatment protocols and conducting collaborative clinical research. Oryzon is collaborating with CETLAM and supplying iadademstat for the study.
“VIVALDI expands our clinical investigation of iadademstat in AML in Spain through our collaboration with CETLAM’s prestigious hematology network. In parallel, we are advancing preparations for ALICE-3, our registrational Phase III trial, building on the strong clinical data from ALICE-2 to be presented soon at ASH,” said Carlos Buesa, Chief Executive Officer of Oryzon.
“Our development strategy prioritizes patients with substantial unmet need, including those with TP53 or RAS pathway mutations,” Buesa added. “VIVALDI findings in these populations may also provide complementary insights to inform future regulatory discussions. The study will also help us plan the future European arm of ALICE-3, taking into account the operational differences between conducting the trial in Europe and the United States.”
Dr. Jordi Esteve, President of CETLAM’s Board and Principal Investigator of VIVALDI at Hospital Clínic de Barcelona, said: “We are excited to bring, for the first time, this promising investigational combination to Spanish patients with TP53-mutated AML and other adverse-risk forms of the disease, building on the encouraging early clinical results and favorable tolerability observed in the U.S. ALICE-2 study. VIVALDI will also enable correlative studies to explore the biology underlying treatment response and deepen our understanding of LSD1 inhibition in these particularly difficult-to-treat leukemias.”
Dr. Olga Salamero of Vall d’Hebron University Hospital and co-Principal Investigator in VIVALDI, added: “In the earlier ALICE-1 study, led by our Vall d'Hebron University Hospital/VHIO AML team, iadademstat combined with azacitidine showed encouraging activity, including in patients with particularly poor prognoses, as the TP53+ patients where we saw a remarkable improvement in overall survival. Those findings, published in The Lancet Haematology, together with the emerging ALICE-2 results with the triplet combination, provide a strong scientific rationale for continued investigation through VIVALDI.”
Oryzon is preparing ALICE-3 as a potentially registrational Phase III study of iadademstat in combination with venetoclax and azacitidine in first-line AML, with initiation planned in 2027, subject to regulatory agreement and financing. The Company expects to present final ALICE-2 data at the 2026 American Society of Hematology (ASH) Annual Meeting. The final design of ALICE-3 remains subject to regulatory discussions and review of emerging clinical evidence.
Public information on VIVALDI is available in the Clinical Trials Information System (CTIS) under EU trial number 2026-527464-32-00.