Benzinga | Oct 19, 2020 07:10AM EDT

Aptose Initiates Dosing of CG-806 in Patients with Acute Myeloid Leukemia

Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ:APTO, TSX:APS), a clinical-stage company developing highly differentiated agents that target the underlying mechanisms of cancer, today announced dosing of the first patient with acute myeloid leukemia (AML) in a Phase 1 a/b clinical study with CG-806, the company's oral kinase inhibitor that potently inhibits the wildtype and mutant forms of FLT3 and BTK, and suppresses select clusters of kinases that drive oncogenic signaling pathways. The investigational drug is the only known clinical agent that potently inhibits both FLT3 and BTK, giving it broad therapeutic potential across the spectrum of lymphoid and myeloid hematologic malignancies.

"We diligently and thoughtfully prepared for this trial," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer, "and we are grateful for the opportunity to treat relapsed or refractory AML patients with CG-806. The 450mg starting dose in AML patients was selected because that dose, when administered to CLL patients being treated in a separate Phase 1 a/b trial, appeared safe, well tolerated and achieved plasma exposure levels that effectively inhibited phospho-FLT3 activity, which is a key driver of AML."

Several clinical sites are screening patients for the Phase 1 a/b multicenter, open-label, dose escalation study of safety, pharmacodynamics, and pharmacokinetics of CG-806 in ascending cohorts (3+3 design) to determine the maximum tolerated dose or recommended dose in patients with relapsed or refractory AML.

Separate from the AML trial, Aptose is conducting a Phase 1 a/b dose escalation study with CG-806 in patients with B-cell malignancies, including chronic lymphocytic leukemia (CLL) and non-Hodgkin's lymphomas (NHL), who have failed or are intolerant to current therapies.